Toxicological Evaluation of a Mixture of Astragalus membranaceus and Panax notoginseng Root Extracts (InnoSlim®).

Timothy S Murbach,Gábor Hirka,Adél Vértesi,Erzsébet Béres,John R Endres,Ilona Pasics Szakonyiné,Róbert Glávits

doi:10.1155/2019/5723851

Timothy S Murbach, Gábor Hirka + Show 5 more

Open Access

https://doi.org/10.1155/2019/5723851

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Abstract

Astragalus spp. and Panax spp. have a long history of traditional human use. A blend, InnoSlim®, of highly purified and fractionated root extracts from Astragalus membranaceus and Panax notoginseng has now been developed for human consumption; however, the unique constituent content of this blend has not been specifically evaluated with respect to safety. Therefore, the toxicological potential of the blend was formally investigated in a series of studies—genetic toxicity was evaluated in a bacterial reverse mutation test followed by an in vivo mammalian micronucleus test, and general toxicity was evaluated in a 28-day repeated-dose oral toxicity study in rats. No evidence of mutagenicity was observed in the bacterial tester strains used, and no evidence of in vivo chromosomal damage resulting in increased frequency of micronucleated cells was observed in male Crl:NMRI BR mice. No mortality or toxic effects were observed, and no target organs were identified, in male and female Han:WIST rats exposed to 0, 400, 800, or 1200 mg/kg bw/day of the blend by gavage for 28 consecutive days. The highest dose—1200 mg/kg bw/day—was determined to be the NOAEL. Based on these results, extrapolation towards a safe human consumption level can be explored.

Highlights

Both Astragalus membranaceus and Panax notoginseng roots have long histories of traditional use
InnoSlim5 is an equal mixture of dried extracts of A. membranaceus (10:1 hydroethanolic extract) and P. notoginseng (50:1 aqueous extract) roots blended together with a small amount of maltodextrin as an excipient and its production is compliant with current Good Manufacturing Practice
The studies described were conducted in compliance with OECD Principles of Good Laboratory Practice (GLP) [30], except for the following deviation: analytical control of the test item formulations for homogeneity and stability was not performed because no appropriate test method was available

Summary

Introduction

Both Astragalus membranaceus and Panax notoginseng roots have long histories of traditional use. It is an adaptogen that has been classified as a Qi and blood tonic in the Chinese Materia Medica and has been used in China for general weakness, to invigorate liver and spleen functions, to invigorate “yang”, and for overall vitality [3,4,5,6]. It has been mainly used as raw dried root, honey cured root, or as an aqueous decoction, steeping in ethanol (or “spirits”) has been described [1, 7]. Flavonoids identified in A. membranaceus are calycosin-7-O-훽-D-glucoside, calycosin7-O-훽-D-glucoside-6耠-O-malonate, ononin, (6aR,11aR)-3hydroxy-9,10-dimethoxypterocarpan-3-O-훽-D-glucoside, calycosin, (3R)-7,2耠-dihydroxy-3耠,4耠-dimethoxyisoflavan-7O-훽-D-glucoside, formononetin-7-O-훽-D-glucoside-6耠-Omalonate, and formononetin [13]

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