Objective Quercus infectoria galls (QIG) is being widely used in Traditional Uyghur Medicine. To gather preclinical safety information for the aqueous extract of QIG, a toxicity study was performed. Methods Subject animals were randomized, and devided into exposure and control groups. In the acute toxicity phase, three different doses—5, 7.5, and 10 g/kg, respectively—were administered via enema to imprinting control region (ICR) mice. An experiment using the maximum tolerance dose (MTD) i.e.10 g/kg was also performed. Data were gathered for 14 days, and study parameters were clinical signs, body weight, general behavior, adverse effects and mortality. At the day 14, major organs of the subjects were examined histologically. Chronic toxicity was also evaluated in Wistar rats for over 180 consecutive days. The rats were divided into three groups with different doses of 0.2 g/kg, 0.8 g/kg, and 2 g/kg, QIG. Furthermore, observations were carried out in rabbits to investigate if there were signs of irritation. Results In comparison to control group, acute, chronic toxicity and mortality were not significantly increased in exposure group. Conclusion Study result suggests that the aqueous extract of QIG is unlikely to have significant toxicity and that clinical trials may proceed safely.
References
[1]
Chopra RN, Nayar SI, Chopra IC (1956) Glossary of Indian medicinal plant. C. S.I. R. New Delhi India.208: 255–256.
[2]
Kaur G, Athar M, Alam MS (2008) Quercus infectoria Galls possess antioxidant activity and abrogates oxidative stress-induced functional alterations in murine macrophages. Chem Biol Interac171: 272–282. doi: 10.1016/j.cbi.2007.10.002
[3]
Everest A, Ozturk E (2005) Focusingon ethnobotanical uses of plants in Mersin and Adana provinces (Turkey) Journal Ethnobiology. Ethno medicine 1: 1–6.
[4]
Hamid H, Kaur G, Abdullah ST, Ali M, Athar M, et al. (2005) Two new compounds from the galls of Quercus infectoria with nitric oxide and superoxide inhibiting ability. Pharma Biol 43: 317–323. doi: 10.1080/13880200590951711
[5]
Yamunarani K, Jaganathan R, Bhaskaran P, Govindaraju R, Velazhahan R (2005) In vitro Antifungal Activity of a 29-kDa Glycoprotein Purified from the Galls of Quercus infetoria. Acta Phytopath Entomol Hungarica 40: 43–54. doi: 10.1556/aphyt.40.2005.1-2.6
[6]
Hwang JK, Kong TW, Baek NI, Pyun YR (2000) Alpha-glycosidase inhibitory activity of hexagalloylglucose from the galls of Quercus infectoria. Planta Med 66: 273–274. doi: 10.1055/s-2000-8569
[7]
Dar MS, Ikram M (1979) Studies on Quercus infectoria; isolation of syringic acid and determination of its central depressive activity. Planta Med 35: 156–161. doi: 10.1055/s-0028-1097197
[8]
Kaur G, Hamid H, Ali A, Alam MS, Athar M (2004) Antiinflammatory evaluation of alcoholic extract of galls of Quercus infectoria. J Ethnopharmacol 90: 285–292. doi: 10.1016/j.jep.2003.10.009
[9]
Dar MS, Ikram M, Fakouhi T (1976) Pharmacology of Quercus infectoria, J Pharm Sci. 65: 1791–94. doi: 10.1002/jps.2600651224
[10]
Ikram M, Nowshad F (1977) Constituents of Quercus infectoria. Planta Med31: 286–287. doi: 10.1055/s-0028-1097531
[11]
Ren Yuan (2005) Study on chemical constituents of Turkish galls and Preparation Kuijie'an enema[D].Urumqi: Xinjiang Medical University.
[12]
Wang JY, Zhang QH, Deng XM, Wang DC, Han WY (2007) Progress on pharmacological activities of Quercus infectoria galls. Shizhen Guoyi Guoyao 18: 2570–2572.
[13]
Guo XY, Kurexi Y, Huang JJ, Huang GH, Yang M, et al. (2009) Effect of Xi pa yi Kuijie'an on COX-2 gene expression in rat ulcerative colitis. Disi Junyida Xuebao 30: 501–504.
[14]
Nassirhadjy M, KoreshY, Parhat A, DilbarW, Halmurat U (2007) The effection of QIG to rat IL-6 gene at mRNA level. Xinjiang Yike da Xuebao 29: 935–938.
[15]
He J, Wufuer H, Huang JJ, Wu J, Yunusi K (2009) Xipayi Kui Jie'an downregulates c-jun expression in rat ulcerative colitis. World J Gastroenterol 15: 3441–3445.
[16]
Huang JJ, Yunusi K, He J, Ni Q, Chen Y, et al. (2010) Xipayi Kui Jie'an downregulates iNOS expression in rat ulcerative colitis. World J Gastroenterol 16: 350–354.
[17]
Wu HL, Mao XM, Zhang FY, Halmurat U (2005) Effects of KuiJie'an on platelet agglomeration in rabbits and ulcerative colitis rats. Xinjiang Yikeda Xuebao 28: 35–37.
[18]
National Pharmacopoeia Committee (2005) Pharmacopoeia of Peoples Republic of China [M]. Part 1 Beijing: Chemical Industry Press: Appendix VlB,VllG,XB,VlA,VlllC.
[19]
Mubarak I, Dilnur A, Zeng CL, Halmurat H (2012) Study on the quality standard of Xipayi Kuijie'an Enema. China journal of hospital pharmacy 32: 1397–1399.
[20]
Mubarak I, Kurax Y, Mawlanjan H, Halmurat H, Li YJ (2011) Experimental Study on Effects of Uyghur Mmedicine Xipayi Kuijie'an on Colon Mucosa Apoptosis and Mechanism of Treating Ulcerative Colitis. Science and Technology Review 29: 29–35.
[21]
Twaij HAA, Kery A, Al Khazraji NK (1983) Some pharmacological, toxicological and phytochemical investigations on Centaurea phyllocephala. J Ethnopharmacol 9: 299–314. doi: 10.1016/0378-8741(83)90037-5
[22]
Cooper EL, CAM eCAM (2005) Bioprospecting: The 21st century pyramid. Evid Based Complement and Alternat Med 2: 125–127. doi: 10.1093/ecam/neh094
[23]
Cooper EL (2004) Drug discovery, CAM and natural products. Evid Based Complement and Alternat Med 1: 215–217. doi: 10.1093/ecam/neh032
[24]
Tsao JCI, Zeltzer LK (2005) Complementary and alternative medicine approaches for pediatric pain: a review of the state-of-the-science. Evid Based Complement and Alternat Med 2: 149–159. doi: 10.1093/ecam/neh092
[25]
Kouitcheu Mabeku LB, Penlap Beng V, Kouam J, Essame O, Etoa FX (2007) Toxicological evaluation of ethyl acetate extract of Cylicodiscus gabunensis stem bark (Mimosaceae). J Ethnopharmacol 111: 598–606. doi: 10.1016/j.jep.2007.01.010
[26]
Zhu M, Lew KT, Leung P (2002) Protective effects of plants formula on ethanol- induced gastric lesions in rats. Phytother Res 16: 276–280. doi: 10.1002/ptr.839
[27]
Brock WJ, Trochimowicz HJ, Millischer RJ, Farr C, Kawano T, et al. (1995) Acute and sub-chronic toxicity of 1,1-dichloro-1-fluoroethane (HCFC-141b). Food Chem. Toxicology 33: 483–490. doi: 10.1016/0278-6915(95)00008-p
[28]
Qin Y, Wu X, Huang W, Gong G, Li D, et al. (2009) Acute toxicity and sub-chronic toxicity of steroidal saponins from Dioscorea zingiberensis C.H.Wright in rodents. J Ethnopharmacol 126: 543–550. doi: 10.1016/j.jep.2009.08.047
[29]
Olson H, Betton G, Robinson D, Thomas K, Monro A, et al. (2000) Concordance of toxicity of pharmaceuticals in humans and in animals. Regular Toxicol and Pharmacol 32: 56–67. doi: 10.1006/rtph.2000.1399
[30]
Onderdonk AB (1985) Experimental Models for Ulcerative Colitis. Dig Dis Sci12 Supp: 40S–44S. doi: 10.1007/bf01296973
