Keywords: Aralia continetalis Kitagawa; Kaurenoic acid; Phase I; Pharmacokinetics; Ultra-performance liquid chromatography-tandem mass spectrometry
Abbreviations:
AIC, akaike information criteria; AUC0-∞, the area under the concentration–time curve from zero to infinity; CL/F, the total body clearance for oral administration; Cmax, the maximum plasma concentration; CV, coefficient of variation; HPLC, high-performance liquid chromatography; ka, the absorption rate constant; IS, internal standard; LLE, liquid–liquid extraction; LLOQ, lower limit of quantification; MRM, multiple reaction monitoring; PK, pharmacokinetic; QC, quality control; t1/2, the terminal half time, Tmax, the time to reach Cmax, UPLC-MS/MS, ultra-performance liquid chromatography-tandem …show more content…
Its dried root, Araliae Continentalis Radix, is a perennial herb that has been widely used for therapeutic uses such as rheumatism, lumbago, and lameness (Lim et al., 2009), and it has antinociceptive (Park et al., 2005), antidementia (Cho et al., 2009), antioxidant (Liu et al., 2010), anticancer (Cheng et al., 2011; Huh et al., 2011), and anti-inflammatory activities (Kim et al., 2010). Araliae Continentalis Radix has been administered as Du huo Ji Sheng Tang, which is a combination decoction containing Araliae Continentalis Radix, Sang Ji Sheng, Du Zhong, Niu Xi, Qin Jiao, Fu Ling, Rou Gui, Fang Feng, Ren Shen, Chuan Xiong Dang Gui, Bai shao, Sheng Di Huang, Gan cao, and Xi Xin in east …show more content…
All the subjects participated in this study after providing written informed consent. The study protocol was approved by the Institutional Review Board of the Oriental Medicine Hospital of Dongshin University, Suncheon-si, Jeollanam-do, Korea (https://cris.nih.go.kr No. KCT0001211). This study was carried out according to the revised Declaration of Helsinki for biomedical research involving human subjects and the rules of Good Clinical Practice. The subjects were in good health prior to the study as confirmed by physical examination, medical history, and laboratory tests (blood analysis; hemoglobin, hematocrit, RBC, WBC, platelet, albumin, total cholesterol and triglyceride, hepatic function test; ALP, ALT and AST, and renal function test; BUN, creatinine, and CrCl). The volunteers were selected if there was no possibility of their being sensitive to this medication and had no history of illness of the hepatic, renal or cardiovascular systems, or no history of excessive alcohol intake or other medications. The demographic characteristics of the 10 subjects participated in this clinical study are summarized in Table 1. All the subjects fasted for at least 10 h before the administration of the extract powder and continued to fast for 4 h thereafter. They abstained from the consumption of alcohol or xanthine-containing foods and
Abbreviations:
AIC, akaike information criteria; AUC0-∞, the area under the concentration–time curve from zero to infinity; CL/F, the total body clearance for oral administration; Cmax, the maximum plasma concentration; CV, coefficient of variation; HPLC, high-performance liquid chromatography; ka, the absorption rate constant; IS, internal standard; LLE, liquid–liquid extraction; LLOQ, lower limit of quantification; MRM, multiple reaction monitoring; PK, pharmacokinetic; QC, quality control; t1/2, the terminal half time, Tmax, the time to reach Cmax, UPLC-MS/MS, ultra-performance liquid chromatography-tandem …show more content…
Its dried root, Araliae Continentalis Radix, is a perennial herb that has been widely used for therapeutic uses such as rheumatism, lumbago, and lameness (Lim et al., 2009), and it has antinociceptive (Park et al., 2005), antidementia (Cho et al., 2009), antioxidant (Liu et al., 2010), anticancer (Cheng et al., 2011; Huh et al., 2011), and anti-inflammatory activities (Kim et al., 2010). Araliae Continentalis Radix has been administered as Du huo Ji Sheng Tang, which is a combination decoction containing Araliae Continentalis Radix, Sang Ji Sheng, Du Zhong, Niu Xi, Qin Jiao, Fu Ling, Rou Gui, Fang Feng, Ren Shen, Chuan Xiong Dang Gui, Bai shao, Sheng Di Huang, Gan cao, and Xi Xin in east …show more content…
All the subjects participated in this study after providing written informed consent. The study protocol was approved by the Institutional Review Board of the Oriental Medicine Hospital of Dongshin University, Suncheon-si, Jeollanam-do, Korea (https://cris.nih.go.kr No. KCT0001211). This study was carried out according to the revised Declaration of Helsinki for biomedical research involving human subjects and the rules of Good Clinical Practice. The subjects were in good health prior to the study as confirmed by physical examination, medical history, and laboratory tests (blood analysis; hemoglobin, hematocrit, RBC, WBC, platelet, albumin, total cholesterol and triglyceride, hepatic function test; ALP, ALT and AST, and renal function test; BUN, creatinine, and CrCl). The volunteers were selected if there was no possibility of their being sensitive to this medication and had no history of illness of the hepatic, renal or cardiovascular systems, or no history of excessive alcohol intake or other medications. The demographic characteristics of the 10 subjects participated in this clinical study are summarized in Table 1. All the subjects fasted for at least 10 h before the administration of the extract powder and continued to fast for 4 h thereafter. They abstained from the consumption of alcohol or xanthine-containing foods and