- Volume 21 Issue 6
랫드를 이용한 황기의 지상부 추출물에 대한 90일 반복경구투여 독성시험
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Park, Yeong Chul;Lee, Ji Sun;Kim, Dong Yoon;Son, Hye Young;Lee, Jung Woo;Cheoi, Yu Soon;Kim, Kwang Ki;Yu, Chang Yeon;Chung, Ill Min;Im, Moo Hyeog;Lee, Kyung Jae;Choi, Ri Na;Shim, Hoon Seob;Lim, Jung Dae
- 투고 : 2013.09.06
- 심사 : 2013.11.27
- 발행 : 2013.12.30
Pharmacological studies and clinical practices have indicated that Radix Astragali, a dried root of Astragalus membranaceus possesses a lot of biological activities, including antioxidant, hepatoprotective, anti-diabetic, tonic, diuretic, antimicrobial, antiviral, and immunological activities. These biological activities approved by the modern pharmacological studies are mainly due to the constituents of Astragalus membranaceus including polysaccharides, saponins, flavonoids, amino acids, and trace elements. In resent, the main constituents in the root part showing a lot of biological activities has been isolated also from the aboveground parts such as leaves and sprouts in our laboratory. However, the safety evaluation for the aboveground parts of Astragalus membranaceus should be checked before expanding their application as one of food. In the study, a 90-day rat oral gavage study has been conducted with the extracts from Astragalus membranaceus-above-ground parts at doses of 1000, 3000, and 5000mg/kg/day. The following endpoints were evaluated: clinical observations, body weight, gross and microscopic pathology, clinical chemistry, and hematology. Based on the analysis of these endpoints, it was estimated that NOEL (no observed effect level) for male rats and NOAEL (no observed adverse effect level) for female rats are 5000mg/kg/day of the water-extracts from Astragalus membranaceus-aboveground parts.
Astragalus membranaceus;Aboveground Parts;NOAEL;Toxicity
- Bedir E, Calis I, Piacente S, Pizza C and Khan IA. (2000). A new flavonol glycoside from the aerial parts of Astragalus vulneraria. Chemical and Pharmaceutical Bulletin. 48:1994-1995. https://doi.org/10.1248/cpb.48.1994
- He ZQ and Findlay JA. (1991). Constituents of Astragalus membranaceus. Journal of Natural Products. 54:810-815. https://doi.org/10.1021/np50075a009
- Hong SY. (2011). Analysis of gut mucosal immune active polysaccharides and biological active compounds in aboveground parts of Astragalus membranaceus. Master Thesis. Kangwon National University. p.31-53.
- Jeon YH, Moon JW, Kweon HJ, Jeoung YJ, An CS, Jin HL, Hur SJ and Lim BO. (2010). Effects of Lycii fructus and Astragalus membranaceus mixed extracts on immunomodulators and prevention of diabetic cataract and retinopathy in streptozotocin-induced diabetes rat model. Korean Journal of Medicinal Crop Science. 18:15-21.
- Jiao Y, Wen J and Yu X. (1999). Influence of flavonoid of Astragalus membranaceus’s stem and leaves on the function of cell mediated immunity in mice. Zhongguo Zhong Xi Yi Jie He Za Zhi. 19:356-358.
- Kim SH, Jun YM, Lim JJ, Kim SH, Chung IM and Kim EH. (2012). Variation of astrogalosides contents in cultivated Astragalus membranaceus. Korean Journal of Medicinal Crop Science. 20:372-380. https://doi.org/10.7783/KJMCS.2012.20.5.372
- Kitagawa I, Wang H, Saito M and Yoshikawa M. (1983). Saponin and sapogenol. XXXVII: Chemical constituents of Astragali Radix, the root of Astragalus membranaceus Bunge. (4): Astragalosides VII and VIII. Chemical & Pharmaceutical Bulletin. 31:716-722. https://doi.org/10.1248/cpb.31.716
- Lewis RW, Billington R, Debryune E, Gamer A, Lang B and Carpanini F. (2002). Recognition of adverse and nonadverse effects in toxicity studies. Toxicologic Pathology. 30:66-74. https://doi.org/10.1080/01926230252824725
- Lim JD, Yu CY, Cheoi DS, Cheoi YS, Chung IM and Hong SY. (2009). Polysaccharide extracted from above ground part Astragalus membranaceus and pharmaceutical composition comprising the same. Korea. Patent. 10-0994444.
- Ministry of Agriculture and Forestry(MAF). (2002) Development of immuno-stimulators using extracts from the leaves of Panax ginseng C. A. Meyer. Ministry of Agriculture and Forestry. Sejong, Korea. p.182-197.
- Organization for Economic Co-operation and Development (OECD). (2008). OECD Guidelines 408 for the testing of chemicals: Repeated Dose 90 day oral toxicity study in oodents. Organization for Economic Co-operation and Development. Paris, France. p.1-10.
- Osman H, Nasarudin R and Lee SL. (2004). Extracts of cocoa (Theobroma cacao L.) leaves and their antioxidation potential. Food Chemistry. 86:41-46. https://doi.org/10.1016/j.foodchem.2003.08.026
- Park YC and Cho MH. (2011). A new way in deciding NOAEL based on the findings from GLP-toxicity test. Toxicology Research. 27:133-135. https://doi.org/10.5487/TR.2011.27.3.133
- Toda S and Shirataki Y. (1999). Inhibitory effects of Astragali radix, a crude drug in oriental medicines, on lipid peroxidation and protein oxidative modification by copper. Journal of Ethnopharmacology. 68:331-333. https://doi.org/10.1016/S0378-8741(99)00104-X
- United States of Food and Drug Administration(USFDA). (2005). Guidance for industry estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers. Pharmacology and Toxicology. United States of Food and Drug Administration. Rockville. MD, USA. p.5-6.
- Yu QT, Li P, Bi ZM, Luo J and Gao XD. (2007). Two new saponins from the aerial part of Astragalus membranaceus var. mongholicus. Chinese Chemical Letters. 18:554-556. https://doi.org/10.1016/j.cclet.2007.03.025
- Zhong RZ, Yu M, Liu HW, Sun HX, Cao Y and Zhoua DW. (2012). Effects of dietary Astragalus polysaccharide and Astragalus membranaceus root supplementation on growth performance, rumen fermentation, immune responses, and antioxidant status of lambs. Animal Feed Science and Technology. 174:60-67. https://doi.org/10.1016/j.anifeedsci.2012.02.013
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