Intravenous Single-dose Toxicity of Mountain Ginseng Pharmacopuncture in Sprague-Dawley Rats

Abstract

Objectives:Mountain ginseng pharmacopuncture (MGP) is an extract distilled from either mountain cultivated ginseng or mountain wild ginseng. This is the first intravenous injection of pharmacopuncture in Korea. The word intravenous does not discriminate between arteries, veins, and capillaries in Oriental Medicine, but only the vein is used for MGP. The aim of this study is to evaluate the intravenous injection toxicity of MGP through a single-dose test in Sprague-Dawley (SD) rats.Methods:Male and female 6-week-old SD rats were injected intravenously with MGP (high dosage of 20 mL/kg or low dosage of 10 mL/kg). Normal saline was injected into the rats in the control group by using the same method. After the rats has treated, we conducted clinical observations, body-weight measurements and histological observations.Results:In this study, no mortalities were observed in any of the experimental groups. Also, no significant changes by the intravenous injection of MGP were observed in the body weights, or the histological observations in any of the experimental groups compared to the control group. The lethal dose for intravenous injection of MGP was found to be over 20 mL/kg in SD rats.Conclusion:Considering that the dosage of MGP generally used each time in clinical practice is about 0.3 mL/kg, we concluded with confidence that MGP is safe pharmacopuncture.

Single-dose Intravenous Toxicology Testing of Daebohwalryeok Pharmcopuncture in Sprague-Dawley Rats

“…Daebohwalryeok pharmacopuncture (DHRP) is a kind of BQRP that boosts energy, and it is used for general weakness and fatigue [ 2 ]. The indications of DHRP are similar to those of MGP and SGHRP [ 4 - 6 ]. SGHRP has been mainly applied in clinics by using intramuscular or subcutaneous methods.…”

“…SD rats (Orientbio Inc., Korea) were used in this study as they are widely used for toxicity tests [ 3 - 4 , 6 ]. Basic visual examinations were done for incoming animals, which were followed by weight measurements with an electronic scale (CP3202S, Sartorius, Germany).…”

“…DHRP, with the same dosage methods and development purposes of MGP, was developed for intravenous administration to increase the effect of SGHRP. Even though toxicity is critical for intravenous injections, studies on the intravenous injection of DHRP have no yet proven its safety whereas studies on the intravenous single-dose toxicity of MGP and on the intramuscular single-dose toxicity of SGHRP have reported those pharmacopunctures to be safe under those injection conditions [ 4 , 6 ]. Thus, intravenous injection toxicity tests of DHRP are necessary prior to its application.…”

A 4-Week, Repeated, Intravenous Dose, Toxicity Test of Mountain Ginseng Pharmacopuncture in Sprague-Dawley Rats

“…No toxicity had been observed during 10- or 20-mL/kg intravenous- injection, single-dose tests of MGP in SD rats [6], so in this 4-week, repeated study, we set the new maximum single dose at 10 mL/kg. MGP was administered to the rats by intravenous injection in the caudal vein at a rate of 2 mL/min once daily for 4 weeks.…”

“…No significant changes were observed in a randomized, controlled trial of MGP [5], and an intravenous, single-dose toxicity test of MGP in Sprague-Dawley (SD) rats showed no side effects [6]. Thus, we conducted a 4-week, repeated, intravenous dose, toxicity test of MGP in SD rats as part of a safety evaluation of using MGP in SD rats.…”