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Single-dose Toxicity of Water-soluble Ginseng Pharmacopuncture Injected Intramuscularly in Rats.

Yu J, Sun S, Lee K, Kwon K - J Pharmacopuncture (2015)

Bottom Line: No deaths were found in this single-dose toxicity test of intramuscular injections of GP, and no significant changes in the general conditions, body weights, hematological and biochemistry tests, and autopsies were observed.These results suggest that GP is relatively safe.Further studies, including a repeated toxicity test, are needed to provide more concrete evidence for the safety of GP.

View Article: PubMed Central - PubMed

Affiliation: Department of Sasang Constitutional Medicine, Sangji University College of Korean Medicine, Wonju, Korea.

ABSTRACT

Objectives: Radix Ginseng has been traditionally used as an adaptogen that acts on the adrenal cortex and stimulates or relaxes the nervous system to restore emotional and physical balance and to improve well-being in cases of degenerative disease and/or old age. Radix Ginseng has been used for a long time, but the safety of ginseng pharmacopuncture needs testing. This study was done to analyze the single-dose toxicity of water-soluble ginseng pharmacopuncture (GP) intramuscular injections in rats.

Methods: All experiments were performed at Biotoxtech, an institution authorized to perform non clinical studies under the regulations of Good Laboratory Practice (GLP). Each group contained 10 Sprague-Dawley rats, 5 males and 5 females. GP was prepared in a sterile room at the Korean Pharmacopuncture Institute under regulations of Good Manufacturing Practice (GMP). GP dosages were 0.1, 0.5 and 1.0 mL for the experimental groups; normal saline was administered to the control group. The animals general condition was examined daily for 14 days, and the rats were weighed on the starting day and at 3, 7 and 14 days after administration of the pharmacopuncture. Hematological and biochemistry tests and autopsies were done to test the toxicological effect of GP after 14 days. This study was performed with approval from the Institutional Animal Ethics Committee of Biotextech.

Results: No deaths were found in this single-dose toxicity test of intramuscular injections of GP, and no significant changes in the general conditions, body weights, hematological and biochemistry tests, and autopsies were observed. The local injection site showed no changes. Based on these results, the lethal dose was assumed to be over 1.0 mL/animal in both sexes.

Conclusion: These results suggest that GP is relatively safe. Further studies, including a repeated toxicity test, are needed to provide more concrete evidence for the safety of GP.

No MeSH data available.


Related in: MedlinePlus

HPLC-UV chromatograms of ginseng root extracts. HPLC, high performance liquid chromatography; UV, ultra violet.
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Figure 001: HPLC-UV chromatograms of ginseng root extracts. HPLC, high performance liquid chromatography; UV, ultra violet.

Mentions: The water soluble ginseng pharmacopuncture was prepared in a sterile room at the Korean Pharmacopuncture Institute (Korea-Good Manufacturing Practice, K-GMP). After the mixing process with pure water had been completed, the pH was controlled to between 7.0 and 7.5; then, NaCl was added to make a 0.9% isotonic solution. The completed extract was stored in a refrigerator (2.1 ─ 6.6°C). A high performance liquid chromatography (HPLC) analysis was performed to determine the changes in the chemical constituents in ginseng saponin following the enzyme treatment. HPLC results showed the appearance of new peaks (Rh1, Rg3, protopanaxtriol (PPT), Compound K, and Rh2), indicative of ginseng saponin metabolites (Fig. 1, Table 1).


Single-dose Toxicity of Water-soluble Ginseng Pharmacopuncture Injected Intramuscularly in Rats.

Yu J, Sun S, Lee K, Kwon K - J Pharmacopuncture (2015)

HPLC-UV chromatograms of ginseng root extracts. HPLC, high performance liquid chromatography; UV, ultra violet.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4481402&req=5

Figure 001: HPLC-UV chromatograms of ginseng root extracts. HPLC, high performance liquid chromatography; UV, ultra violet.
Mentions: The water soluble ginseng pharmacopuncture was prepared in a sterile room at the Korean Pharmacopuncture Institute (Korea-Good Manufacturing Practice, K-GMP). After the mixing process with pure water had been completed, the pH was controlled to between 7.0 and 7.5; then, NaCl was added to make a 0.9% isotonic solution. The completed extract was stored in a refrigerator (2.1 ─ 6.6°C). A high performance liquid chromatography (HPLC) analysis was performed to determine the changes in the chemical constituents in ginseng saponin following the enzyme treatment. HPLC results showed the appearance of new peaks (Rh1, Rg3, protopanaxtriol (PPT), Compound K, and Rh2), indicative of ginseng saponin metabolites (Fig. 1, Table 1).

Bottom Line: No deaths were found in this single-dose toxicity test of intramuscular injections of GP, and no significant changes in the general conditions, body weights, hematological and biochemistry tests, and autopsies were observed.These results suggest that GP is relatively safe.Further studies, including a repeated toxicity test, are needed to provide more concrete evidence for the safety of GP.

View Article: PubMed Central - PubMed

Affiliation: Department of Sasang Constitutional Medicine, Sangji University College of Korean Medicine, Wonju, Korea.

ABSTRACT

Objectives: Radix Ginseng has been traditionally used as an adaptogen that acts on the adrenal cortex and stimulates or relaxes the nervous system to restore emotional and physical balance and to improve well-being in cases of degenerative disease and/or old age. Radix Ginseng has been used for a long time, but the safety of ginseng pharmacopuncture needs testing. This study was done to analyze the single-dose toxicity of water-soluble ginseng pharmacopuncture (GP) intramuscular injections in rats.

Methods: All experiments were performed at Biotoxtech, an institution authorized to perform non clinical studies under the regulations of Good Laboratory Practice (GLP). Each group contained 10 Sprague-Dawley rats, 5 males and 5 females. GP was prepared in a sterile room at the Korean Pharmacopuncture Institute under regulations of Good Manufacturing Practice (GMP). GP dosages were 0.1, 0.5 and 1.0 mL for the experimental groups; normal saline was administered to the control group. The animals general condition was examined daily for 14 days, and the rats were weighed on the starting day and at 3, 7 and 14 days after administration of the pharmacopuncture. Hematological and biochemistry tests and autopsies were done to test the toxicological effect of GP after 14 days. This study was performed with approval from the Institutional Animal Ethics Committee of Biotextech.

Results: No deaths were found in this single-dose toxicity test of intramuscular injections of GP, and no significant changes in the general conditions, body weights, hematological and biochemistry tests, and autopsies were observed. The local injection site showed no changes. Based on these results, the lethal dose was assumed to be over 1.0 mL/animal in both sexes.

Conclusion: These results suggest that GP is relatively safe. Further studies, including a repeated toxicity test, are needed to provide more concrete evidence for the safety of GP.

No MeSH data available.


Related in: MedlinePlus