Evaluation of the genotoxic potential and acute oral toxicity of standardized extract of Andrographis paniculata (KalmCold™)

Food and Chemical Toxicology

Volumn 47, Issue 8, 2009, Pages 1892-1902

  Chandrasekaran, C V ^a   Thiyagarajan, P ^a   Sundarajan, K ^a   Goudar, Krishna S ^a   Deepak, M ^a   Murali, B ^a   Joshua Allan, J ^a   Agarwal, Amit ^a  

^a Natural Remedies Pvt Ltd   (India)

Author keywords

Acute oral toxicity; Ames test; Andrographis paniculata; CHO K1 cells; Chromosomal aberrations; Micronucleus

Indexed keywords

11,12 DIDEHYDRO 14 DEOXYANDROGRAPHOLIDE; 5 HYDROXY 7,8 DIMETHOXYFLAVONE; ANDROGRAPANIN; ANDROGRAPHOLIDE; DIMETHYL SULFOXIDE; FLAVONE DERIVATIVE; ISOANDROGRAPHOLIDE; KALMCOLD; NEOANDROGRAPHOLIDE; PLANT MEDICINAL PRODUCT; SKULLCAPFLAVONE; UNCLASSIFIED DRUG;

ACUTE TOXICITY; AMES TEST; ANDROGRAPHIS PANICULATA; ANIMAL CELL; ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; BACTERIAL STRAIN; CELL STRAIN; CHROMOSOME ABERRATION; CONTROLLED STUDY; DRUG STRUCTURE; FEMALE; GENOTOXICITY; IN VITRO STUDY; MICRONUCLEUS; MOUTH DISEASE; MUTAGENESIS; NONHUMAN; RAT; SALMONELLA TYPHIMURIUM; STRUCTURE ANALYSIS;

ANDROGRAPHIS; ANIMALS; BIOTRANSFORMATION; CHO CELLS; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CHROMOSOME ABERRATIONS; CRICETINAE; CRICETULUS; FEMALE; MALE; MICRONUCLEUS TESTS; MUTAGENICITY TESTS; MUTAGENS; PLANT EXTRACTS; QUALITY CONTROL; RATS; RATS, WISTAR; REFERENCE STANDARDS; SALMONELLA TYPHIMURIUM; SOLUTIONS; SPECTROPHOTOMETRY, ULTRAVIOLET;

ANDROGRAPHIS PANICULATA; RATTUS; SALMONELLA TYPHIMURIUM;

EID: 68949083369     PISSN: 02786915     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.fct.2009.05.006     Document Type: Article

References (56)

1. Akbarsha M.A., Manivannan B., Hamid K.S., and Vijayan B. Antifertility effect of Andrographis paniculata (Nees) in male albino rat. Indian J. Exp. Biol. 28 (1990) 421-426
2. Avani G., and Rao M.V. In vitro cytogenetic effects of Andrographis paniculata (kalmegh) on arsenic. Phytomedicine 15 (2008) 221-225
3. Boobis A.R., Lynch A.M., Murray S., Torre R.D.L., Solans A., Farre M., Segura J., Gooderham N.J., and Davies D.S. CYPIA2-catalysed conversion of dietary heterocyclic amines to their proximate carcinogens is their major route of metabolism in humans. Cancer Res. 54 (1994) 89-94
4. Caceres D.D., Hancke J.L., Burgos R.A., and Wikman G.K. Prevention of common colds with Andrographis paniculata dried extract: a pilot double-blind trial. Phytomedicine 4 (1997) 101-104
5. Calabrese C., Berman S.H., Babish J.G., Ma X., Shinto L., Dorr M., Wells K., Wenner C.A., and Standish L.J. A phase I trial of andrographolide in HIV positive patients and normal volunteers. Phytother. Res. 14 (2000) 333-338
6. Chander R., Srivastava V., Tandon J.S., and Kapoor N.K. Antihepatotoxic activity of diterpenes of Andrographis paniculata (Kal-Megh) against Plasmodium Berghei-Induced hepatic damage in Mastomys natalensis. Int. J. Pharmacogn. 33 (1995) 135-138
7. Chen W., and Liang X. Deoxyandrographolide 19 β-d-glucoside from the leaves of A. paniculata. Planta Med. 15 (1982) 245-246
8. Coon J.T., and Ernst E. Andrographis paniculata in the treatment of upper respiratory tract infections: a systematic review of safety and efficacy. Planta Med. 70 (2004) 293-298
9. Cui X.S., Eriksson L.C., and Möller L. Formation and persistence of DNA adducts during and after a long-term administration of 2-nitrofluorene. Mutat. Res. 442 (1999) 9-18
10. Dias F.D.L., and Takahashi C.S. Cytogenetic evaluation of aqueous extracts of the medicinal plants Alpinia mutans rose (Zingerberaceae) and Pogostemum hyneanus benth (Labitae) on Wistar rats and Allium cepa (Liliaceae) root tip cells. Rev. Brasil Genet. 17 (1994) 175-180
11. Erexson L.G., Periago M.V., and Spicer C.S. Differential sensitivity of Chinese hamster V79 and Chinese hamster ovary (CHO) cells in vitro micronucleus screening assay. Mutat. Res. 495 (2001) 75-80
12. Farah M., Meyboom R., and Ploen M. Acute hypersensitivity reactions to Andrographis paniculata containing products as reported in international pharmacovigilance. Drug Safety 31 (2008) 885-960
13. Fenech M. The in vitro micronucleus technique. Mutat. Res. 455 (2000) 81-95
14. TM assay: a collaborative study with 19 coded compounds. Mutat. Res. 558 (2004) 181-197
15. Gupta S., Yadava J.N.S., and Tandon J.S. Antisecretory (antidiarrhoeal) activity of Indian medicinal plants against Escherichia coli enterotoxin-induced secretion in rabbit and guinea pig ileal loop models. Pharm. Biol. 31 (1993) 198-204
16. Hancke J.L., Burgos R.A., Caceres D.D., and Wikman G.A. A double blind study with a new monodrug Kan Jang: decrease of symptoms and improvement in the recovery from common colds. Phytother. Res. 9 (1995) 559-562
17. Higashimoto M., Purintrapiban J., Kataoka K., Kinouchi T., Vinitketkumnuen U., Akimoto S., Matsumoto H., and Ohnishi Y. Mutagenicity and antimutagenicity of extracts of three species and a medicinal plant in Thailand. Mutat. Res. 303 (1993) 135-142
18. ICH, 2005. ICH Harmonized Tripartite Guideline. Current Step 4 Version. Validation of Analytical Procedures: Text and Methodology Q2 (R1). International Conference of Harmonization.
19. Indian Pharmacoepia (IP), 1966.
20. Iruretagoyena M.I., Tobar J.A., Gonzalez P.A., Sepulveda S.E., Figueroa C.A., Burgos R.A., Hancke J.L., and Kalergis A.M. Andrographolide interferes with T cell activation and reduces experimental autoimmune encephalomyelitis in the mouse. J. Pharmacol. Exp. Ther. 312 (2005) 366-372
21. Jalal M.A.F., Overton D.S., and Rycroft D.S. Formation of three new flavones by differentiating callus cultures of Andrographis paniculata. Phytochemistry 18 (1979) 149-151
22. Jarukamjorn K., and Nemoto N. Pharmacological aspects of Andrographis paniculata on health and its major diterpenoid constituent andrographolide. J. Health Sci. 54 (2008) 370-381
23. Jayakrishna G., Harikishore P., Rao C.V., Gunasekar D., Blond A., and Bodo B. Two new 2'-oxygenated flavonoids from Andrographis elongata. Chem. Pharm. Bull. 49 (2001) 1555-1557
24. Kassie F., Parzefall W., Musk S., Johnson I., Lamprecht G., Sontag G., and Knasmueller S. Genotoxic effects of crude juices from Brassica vegetables and juices and extracts from phytopharmaceutical preparations and spices of cruciferous plants origin in bacterial and mammalian cells. Chem. Biol. Interact. 102 (1996) 1-16
25. Kligler B., Ulbricht C., Basch E., Kirkwood C.D., Abrams T.R., Miranda M., Singh Khalsa K.P., Giles M., Boon H., and Woods J. Andrographis paniculata for the treatment of upper respiratory infection: a systematic review by the natural standard research collaboration. Explore: J. Sci. Healing 2 (2006) 25-29
26. Kuroyanagi M., Sato M., Ueno A., and Nishi K. Flavonoids from Andrographis paniculata. Chem. Pharm. Bull. 35 (1987) 4429-4435
27. Li J., Cheung H.Y., Zhang Z., Chan G.K.L., and Fong W.F. Andrographolide induces cell cycle arrest at G2/M phase and cell death in HepG2 cells via alteration of reactive oxygen species. Eur. J. Pharmacol. 568 (2007) 31-44
28. Maron D.M., and Ames B.N. Revised methods for the Salmonella mutagenicity test. Mutat. Res. 113 (1983) 173-215
29. Matsuda T., Kuroyanagi M., Sugiyama S., Umehara K., Ueno A., and Nishi K. Cell differentiation - inducing diterpenes from Andrographis paniculata Nees. Chem. Pharm. Bull. 42 (1994) 1216-1225
30. Matsushima T., Hayashi M., Matsuoka A., Ishidate Jr. M., Miura K.F., Shimizu H., Suzuki Y., Morimoto K., Ogura H., Mure K., Koshi K., and Sofuni T. Validation study of the in vitro micronucleus test in a Chinese hamster lung cell line (CHL/IU). Mutagenesis 14 (1999) 569-580
31. Mishra S.K., Sangwan N.S., and Sangwan R.S. Andrographis paniculata (Kalmegh): a review. Pharmacog. Rev. 1 (2007) 283-298
32. Namiki M. Antioxidants/antimutagens in food. Crit. Rev. Food Sci. Nutr. 29 (1990) 273-300
33. Nunoshiba T., and Demple B. Potent intracellular oxidative stress exerted by the carcinogen 4 NQO. Cancer Res. 53 (1993) 3250-3252
34. OECD. OECD Guidelines for Testing of Chemicals. No. 471: Bacterial Reverse Mutation Test (1997), Organisation for Economic Co-operation and Development, Paris
35. OECD. OECD Guidelines for Testing of Chemicals. No. 473. In Vitro Mammalian Chromosomal Aberration Test (1997), Organisation for Economic Co-operation and Development, Paris
36. OECD. OECD Guidelines for Testing of Chemicals. No. 420: Acute Oral Toxicity-Fixed Dose Procedure (2001), Organisation for Economic Co-operation and Development, Paris
37. OECD. Guidance Document on Acute Oral Toxicity Testing. OECD Environment, Health and Safety Publications Series on Testing and Assessment No. 24 (2001), Organisation for Economic Co-operation and Development, Paris
38. OECD. OECD Guidelines for Testing of Chemicals. No. 487. In Vitro Micronucleus Test (Draft proposal) (2004), Organisation for Economic Co-operation and Development, Paris
39. Pholphana N., Rangkadilok N., Thongnest S., Ruchirawat S., Ruchirawat M., and Satayavivad J. Determination and variation of three active diterpenoids in Andrographis paniculata (Burm.f.) Nees. Phytochem. Anal. 15 (2004) 365-371
40. Pramanick S., Banerjee S., Achari B., Das B., Sen A.K., Mukhopadhyay S., Neuman A., and Prange T. Andrographolide and isoandrographolide, minor diterpenoids from Andrographis paniculata: structure and X-ray crystallographic analysis. J. Nat. Prod. 69 (2006) 403-405
41. Puri H.S. Kalmegh. In: Hardman R. (Ed). Rasayana: Ayurvedic Herbs for Longevity and Rejuvenation (2003), Taylor and Francis Group, London, New York 151
42. Rahman N.N.N.A., Furuta T., Kojima S., Takane K., and Mohd M.A. Antimalarial activity of extracts of Malaysian medicinal plants. J. Ethnopharmacol. 64 (1999) 249-254
43. Savage J.R.K. Classifications and relationships of induced chromosomal structural changes. J. Med. Gent. 12 (1975) 103-122
44. Schimmer O., Kruger A., Paulini H., and Haefele F. An evaluation of 55 commercial plant extracts in the Ames mutagenicity test. Pharmazie 49 (1994) 448-451
45. Sharma A., Krishan L., and Handa S.S. Standardization of the Indian crude drug Kalmegh by high pressure liquid chromatographic determination of andrographolide. Phytochem. Anal. 3 (1992) 129-131
46. Sharma, P.V., 1983. In: Charaka Samhita (Ed.), Chankhambhia Orientalia, vol. II, Varanasi.
47. Sheeja K., Shihab P.K., and Kuttan G. Antioxidant and anti-inflammatory activities of the plant Andrographis paniculata Nees. Immunopharmacol. Immunotoxicol. 28 (2006) 129-140
48. Snyderwine E.G., Turesky R.J., and Turteltaab K.W. Metabolism of food-derived heterocyclic amines in non-human primates. Mutat. Res. 376 (1997) 203
49. Tetsuro F., Ryujiro F., Yoshio T., Yoshihisa T., Toshihide Y., Masaru K., and Iwao M. On the diterpenoids of Andrographis paniculata: X-ray crystallographic analysis of andrographolide and structure determination of new minor diterpenoids. Chem. Pharm. Bull. 32 (1984) 2117-2125
50. Umar-Tsafe N., Mohamed-Said M., Rosli R., Din B.L., and Lai L.C. Genotoxicity of goniothalamin in CHO cell line. Mutat. Res. 562 (2004) 91-102
51. United States Pharmacoepia (USP), 2007. vol. 1.
52. Verschaeve L., Kestens V., Taylor J.L.S., Elagorashi E.E., Maes A., Puyvelde V.L., DeKimpe N., and Van Staden J. Investigation of the antimutagenic effects of selected South African medicinal plant extracts. Toxicol. In Vitro 18 (2004) 29-35
53. Visen P.K.S., Saraswat B., Vuksan V., and Dhawan B.N. Effect of andrographolide on monkey hepatocytes against galactosamine induced cell toxicity: an in-vitro study. J. Complement. Integr. Med. 4 (2007) 10
54. Wiart C., Kumar K., Yusof M.Y., Hamimah H., Fauzi Z.M., and Sulaiman M. Antiviral properties of ent-labdene diterpenes of Andrographis paniculata Nees, inhibitors of herpes simplex virus type 1. Phytother. Res. 19 (2005) 1069-1070
55. Zhang C.Y., and Tan B.K.H. Mechanisms of cardiovascular activity of Andrographis paniculata in the anaesthetized rat. J. Ethnopharmacol. 56 (1997) 97-101
56. Zhang X. WHO Monographs on Selected Medicinal Plants vol. 2 (2002), World Health Organization, Geneva