Single-dose Intramuscular Injection Toxicology of Danggui Pharmacopuncture (DGP) in Sprague-Dawley Rats

Abstract

Objectives:The purpose of the study is to assess both the approximate lethal dose and the single dose intramuscular injection toxicity of Danggui (Angelica gigantis radix) pharmacopuncture (DGP) in Sprague-Dawley (SD) rats.Methods:The experiments were conducted at the good laboratory practice (GLP) laboratory, Biotoxtech Co., which is a laboratory approved by the ministry of food and drug safety (MFDS). The study was performed according to the GLP regulation and the toxicity test guidelines of the MFDS (2009) after approval of the institutional animal care and use committee of Biotoxtech. Single doses of DGP were injected intramuscularly into the rats in three test groups of 6 week old SD rats (5 male and 5 female rats per groups) in the amounts of 0.1, 0.5, and 1.0 mL/animal for groups 2, 3, and 4, respectively, and normal saline solution in the amount of 1.0 mL/animal was injected intramuscularly into the rats (5 male and 5 female rats) in the control group. Observations of the general symptoms and weight measurements were performed during the 14 day observation period after the injection. Hematologic and serum biochemical examination, necropsy, and a local tolerance test at the injection site were done after the observation period.Results:No death was observed in three test groups (0.1, 0.5 and 1.0 mL/animal group). In addition, the injection of DGP had no effect on general symptoms, weights, hematologic and serum biochemical examination, and necropsy. The results from the local tolerance tests at injection site showed no treatment related effects in the SD rats.Conclusion:The results of single dose intramuscular injection of DGP suggest that the approximate lethal dose is above 1.0 mL/animal for both male and female SD rats and that intramuscular injection of DGP may be safe.

Single-dose Intravenous Injection Toxicity of Water-soluble Danggui Pharmacopuncture (WDP) in Sprague-Dawley Rats

“…DG contains decursin, α-pinene, limonene, decurisinol nodakenen, β-sistosterol, stigmasterol and so on (3) and includes both water-soluble ingredients and essential oil (4). DG enhance axonal regrowth by the induction of GAP-43 expression and retrograde transport of phospho-Erk1/2 protein from the injury site to the cell body after sciatic nerve injury (21).…”

“…DGP, which contains essential oils, is a possibility to be turn sour without being absorbed under the skin. Therefore, WDP has been developed to maximize the effects of essential oils and water-soluble ingredients, and the essential oil component has been developed to facilitate absorption in the body (4). Pharmacopuncture is divided into an intramuscular injection into the acupuncture point and a vascular injection into the vein according to the insertion method.…”

“…AGN is called Cham Dang Gui, namely Korean DG. The root of AGN, namely Angelica gigas radix (AGR), has been used to treat in Korea (3, 4). DG is called ‘female ginseng’ because DG has effect to tonify blood and has been used to treat many female diseases cause by blood deficiency (5, 6).…”

“…So active components of water-soluble DGP (WDP) can absorb the body easily and can represent good effects (4). The original pharmacopuncture is put on meridian points so they are either hypodermic or intramuscular injections.…”

“…Intravenous injections can increase the effects of WDP but as it is processed right into the body without detoxification, safety is the most important aspect. Although there have reports assuring health safety in single toxicity tests for muscles (4), but there haven’t been any safety reports regarding intravenous injections. Therefore, intravenous injection toxicity tests are necessary.…”