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      A subchronic oral toxicity study of Salacia reticulata extract powder in rats

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          Abstract

          The safety of Salacia plant ( Salacia reticulata) extract powder, which is used in Ayurvedic medical practices, was studied in a dose range-finding subchronic toxicity study in Crl:CD Sprague–Dawley rats. Male and female rats were randomly assigned to 4 treatment groups and were treated by oral gavage with 0, 10, 65, and 400 mg/kg body weight/day of the powder for 91 days. Body weight, food consumption, and clinical signs were assessed during the treatment period. Urinalysis, hematology, blood chemistry, and organ weights were determined one day after the final treatment. The animals were euthanized at the end of the treatment and were examined for necropsy and histopathological purposes. No adverse toxicity was observed in the Salacia powder-treated groups with a No Observed Adverse Effect Level of ≧400 mg/kg body weight/day in both male and female SD rats.

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          Salacia reticulata and its polyphenolic constituents with lipase inhibitory and lipolytic activities have mild antiobesity effects in rats.

          Masayuki Yoshikawa, Norihisa Nishida, Hiroshi Shimoda … (2002)
          Salacia (S.) reticulata, a Hippocrateaceae plant distributed in Sri Lankan and Indian forests, has been used as a supplementary food in Japan to prevent obesity and diabetes. We examined the antiobesity effects of the hot water-soluble extract (SRHW) from the roots of S. reticulata using obese rat models and an in vitro study. Body weight (P = 0.07) and periuterine fat storage (P = 0.10) in female Zucker fatty rats (8-9 wk old) tended to be suppressed by oral administration of SRHW (125 mg/kg) for 27 d. Male rats fed a high fat diet were not affected by SRHW. Furthermore, SRHW inhibited porcine pancreatic lipase (PL), rat adipose tissue-derived lipoprotein lipase (LPL) and glycerophosphate dehydrogenase (GPDH) activities with 50% inhibitory concentrations (IC(50)) of 264 (95% confidence limits: 203-393) mg/L, 15 (12-18) mg/L and 54 (35-85) mg/L, respectively, but did not inhibit hormone-sensitive lipase activity in rat adipose tissue. Next, we examined the effects of polyphenols, di- and triterpenes and salacinol isolated from the roots of S. reticulata on lipid metabolizing enzymes and lipolysis. (-)-Epigallocatechin and (-)-epicatechin-(4beta-->8)-(-)-4'-O-methylepigallocatechin inhibited PL activity with IC(50) of 88 (not calculated) and 68 (26-122) mg/L, respectively. (-)-Epicatechin, 3beta, 22beta-dihydroxyolean-12-en-29-oic acid and the tannin fraction inhibited LPL activity with IC(50) of 81 (54-214), 89 (62-214) and 35 (24-62) mg/L. Only the tannin fraction inhibited GPDH activity with an IC(50) of 6.8 (3.4-10.9) mg/L. These constituents may be involved in the lipase and GPDH inhibitory activities of SRHW. On the other hand, SRHW at 100 mg/L tended to enhance lipolysis in rat adipocytes (P = 0.06). Significant lipolytic effects were exerted by mangiferin, (-)-4'-O-methylepigallocatechin and maytenfolic acid at 100 mg/L (P < 0.01). In conclusion, polyphenolic compounds may be involved in the antiobesity effects of SRHW in rats through inhibition of fat metabolizing enzymes (PL, LPL and GPDH) and enhanced lipolysis.
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            A double blind randomised placebo controlled cross over study of a herbal preparation containing Salacia reticulata in the treatment of type 2 diabetes.

            Mónica Bravo, V Hettigoda, Devaka Fernando … (2005)
            We conducted a randomised single centre double blind cross over clinical trial to investigate the effects of a herbal tea containing Salacia reticulata (Kothala Himbutu tea) in patients with type II diabetes mellitus. Fifty-one patients with type II diabetes mellitus for longer than 6 months and with evidence of stable glycaemic control over the preceding 6 months (as assessed by HbA1C) participated in the study. They were randomised to receive a standard preparation of Kothala Himbutu tea for 3 months followed by placebo in similar tea bags for a further 3 months (n = 28) or in reverse order (n = 23). All patients received detailed advice on diet, exercise and lifestyle modification. HbA1C was measured at recruitment, at 3 months and on completion of the study at 6 months. Liver and renal functions were assessed biochemically at baseline, at 3 and 6 months and adverse events were recorded. There were no significant differences between the two groups in age, body mass index, male/female ratio, glycaemic control and baseline laboratory tests. All patients completed both arms of the trial. The HbA1C at the end of drug treatment was significantly lower than after treatment with placebo (6.29 +/- S.D. 1.02 versus 6.65 +/- S.D. 1.04; P = 0.008). A statistically significant fall in HBA1c was seen with the active drug compared to a rise in HbA1C with the placebo group (0. 54 +/- S.D. 0.93) versus -0.3 +/-S.D. 1.05; P < 0.001. The daily mean dose of Glibenclamide fell by 1.89 (S.D. 6.2) mg in the drug treated group but rose by 2.25 mg in the placebo treated group (P = 0.07). The differences in the metformin dose were not significantly significant in the two groups. We conclude that Kothala Himbutu tea is an effective and safe treatment for type 2 diabetes.
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              Absolute stereostructure of potent alpha-glucosidase inhibitor, Salacinol, with unique thiosugar sulfonium sulfate inner salt structure from Salacia reticulata.

              Masayuki Yoshikawa, Toshio Morikawa, Hisashi Matsuda … (2002)
              A most potent alpha-glucosidase inhibitor named salacinol has been isolated from an antidiabetic Ayurvedic traditional medicine, Salacia reticulata WIGHT, through bioassay-guided separation. The absolute stereostructure of salacinol was determined on the basis of chemical and physicochemical evidence, which included the alkaline degradation of salacinol to 1-deoxy-4-thio-D-arabinofuranose and the X-ray crystallographic analysis, to be the unique spiro-like configuration of the inner salt comprised of 1-deoxy-4-thio-D-arabinofuranosyl sulfonium cation and 1'-deoxy-D-erythrosyl-3'-sulfate anion. Salacinol showed potent inhibitory activities on several alpha-glucosidases, such as maltase, sucrase, and isomaltase, and the inhibitory effects on serum glucose levels in maltose- and sucrose-loaded rats (in vivo) were found to be more potent than that of acarbose, a commercial alpha-glucosidase inhibitor.
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                Author and article information

                Contributors
                Yuriko Oda
                Journal
                Journal ID (nlm-ta): Toxicol Rep
                Journal ID (iso-abbrev): Toxicol Rep
                Title: Toxicology Reports
                Publisher: Elsevier
                ISSN (Electronic): 2214-7500
                Publication date PMC-release: 26 July 2015
                Publication date Collection: 2015
                Publication date (Electronic): 26 July 2015
                Volume: 2
                Pages: 1136-1144
                Affiliations
                [a ]Pharmaceutical & Healthcare Research Laboratories, Research & Development Management Headquarters, FUJIFILM Corporation, 577, Ushijima, Kaisei-machi, Ashigarakami-gun, Kanagawa 258-8577, Japan
                [b ]Safety Evaluation Center, FUJIFILM Corporation, 210, Nakanuma, Minamiashigara-shi, Kanagawa 250-1093, Japan
                Author notes
                [* ]Corresponding author. Yuriko.oda@ 123456fujifilm.com
                Article
                Publisher ID: S2214-7500(15)30021-4
                DOI: 10.1016/j.toxrep.2015.07.001
                PMC ID: 5598469
                SO-VID: 92b256b2-6a1d-45ea-afa9-0f5f080c4df1
                Copyright © © 2015 The Authors
                License:

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                Date received : 19 February 2015
                Date revision received : 25 June 2015
                Date accepted : 2 July 2015
                Categories
                Subject: Article

                Keywords: salacia reticulata,subchronic toxicity study,no observed adverse effect level,salacia plant extract powder,sprague–dawley rat,oral administration
                Data availability:
                Keywords: salacia reticulata, subchronic toxicity study, no observed adverse effect level, salacia plant extract powder, sprague–dawley rat, oral administration

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