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. 2015 Dec 9;16(12):29345-56.
doi: 10.3390/ijms161226176.

The Safety Evaluation of Salvianolic Acid B and Ginsenoside Rg1 Combination on Mice

Qun Zhao  1   2 , Min Yang  3 , Yanping Deng  4 , Haitao Yu  5 , Linlin Wang  6 , Fukang Teng  7   8 , Kenka Cho  9 , Hongmei Ma  10 , Peng Wu  11   12 , Xue Li  13 , Wanying Wu  14 , Xuan Liu  15 , Feng Xu  16 , Baohong Jiang  17 , De-An Guo  18
Affiliations

The Safety Evaluation of Salvianolic Acid B and Ginsenoside Rg1 Combination on Mice

Qun Zhao et al. Int J Mol Sci. .

Abstract

Our previous study indicated that the combination of salvianolic acid B (SalB) and ginsenoside Rg1 (Rg1), the main components of Salvia miltiorrhizae and Panax notoginseng, improves myocardium structure and ventricular function in rats with ischemia/reperfusion injury. The present study aimed to determine the safety of the combined SalB and Rg1 (SalB-Rg1) in mice. The safety of SalB-Rg1 was evaluated through acute toxicity and repeated-dose toxicity. In the acute toxicity study, the up and down procedure was carried out firstly, and then, the Bliss method was applied. In the toxicity study for seven-day repeated treatment of SalB-Rg1, forty Kunming mice were randomly divided into four groups. The intravenous median lethal dose (LD50) of the SalB-Rg1 combination was 1747 mg/kg using the Bliss method. For both the acute toxicity study and the seven-day repeated toxicity study, SalB-Rg1 did not induce significant abnormality on brain, heart, kidney, liver and lung structure at any dose based on H&E stain. There were no significant changes related to the SalB-Rg1 toxicity detected on biochemical parameters for two kinds of toxicity studies. The LD50 in mice was 1747 mg/kg, which was more than one hundred times higher than the effective dose. Both studies of acute toxicity and seven-day repeated dose toxicity indicated the safety of the SalB-Rg1 combination.

Keywords: acute toxicity; ginsenoside Rg1; repeated toxicity; safety; salvianolic acid B.

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Figures

Figure 1
Figure 1
Representative chromatograms of salvianolic acid B (SalB) and ginsenoside Rg1 (Rg1). (A) The purity of SalB was 98.46%; and (B) the purity of Rg1 was 98.35%.
Figure 2
Figure 2
The sequence of the up and down procedure. The surviving animals are marked as green circles and the dead animals as a red cross. The initial dose was 175 mg/kg of the SalB-Rg1 combination.
Figure 3
Figure 3
The survival curve for acute toxicity. All of the deaths occurred within 24 h after intravenous administration of SalB-Rg1.
Figure 4
Figure 4
Representative histological pictures of heart (A), kidney (B), spleen (C), brain (D), lung (E) and liver (F) staining with H&E in the acute toxicity study (magnification 400×).
Figure 5
Figure 5
Representative histological pictures of heart (A), kidney (B), spleen (C), brain (D), lung (E) and liver (F) staining with H&E in the seven-day repeated toxicity study (magnification 400×).
See this image and copyright information in PMC

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