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

Qun Zhao,Kenka Cho,Baohong Jiang,Peng Wu,Haitao Yu,Min Yang,Fukang Teng,Feng Xu,Yanping Deng,Hongmei Ma,Wanying Wu,Xue Li,De-An Guo,Linlin Wang,Xuan Liu

doi:10.3390/ijms161226176

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.

Highlights

The herb pair derived from the roots of Salviae miltiorrhizae (Danshen in Chinese) and Panax notoginseng (Sanqi in Chinese) has been widely used for improving coronary or cerebral circulation in China, as well as in Western countries [1,2]
To evaluate the safety of the salvianolic acid B (SalB)-Rg1 combination, we examined acute toxicity and seven-day repeated dose toxicity in mice of both sexes
The therapeutic window is the range of drug dosages that can treat disease effectively while staying within the safety range

Summary

Introduction

The herb pair derived from the roots of Salviae miltiorrhizae (Danshen in Chinese) and Panax notoginseng (Sanqi in Chinese) has been widely used for improving coronary or cerebral circulation in China, as well as in Western countries [1,2]. Our previous study verified the significant cardio-protection for the combination of salvianolic acid B (SalB), the main active ingredient of Salviae miltiorrhizae, with ginsenoside Rg1 (Rg1), the main active ingredient of Panax notoginseng. Intravenous administration of the SalB-Rg1 combination at a ratio of 2:5 improves myocardium structure and ventricular function in rats with ischemia/reperfusion injury [3].

Methods

Results

Conclusion