Acute and Subacute Oral Toxicity Studies and Anti-Sickling Activity Assessment of FACA® Syrup
Abstract
Sickle cell disease remains a major public health problem in Burkina Faso and Africa. For the management of this pathology in young children, the Institute for Research in Health Sciences has developed an herbal drug called FACA® syrup. The objective of this study was to verify the safety and pharmacological efficacy of this formulation for its use in the management of sickle cell disease. Acute and subacute oral toxicity tests were performed on Wistar rats in accordance with Organization for Economic Cooperation and Development test guidelines and anti-sickling activity of FACA® syrup was evaluated according to the Emmel test. In the acute test, FACA® syrup didn’t cause mortality or any behavioral change at dose of 2000 mg/kg/b.w suggesting that the test product estimated LD50 is 5000 mg/kg b.w. The results of subacute toxicity study indicate that the daily administration of FACA® syrup during 28 days did not result in significant change on physical, haematological and biochemical parameters up to dose of 1000 mg/kg b.w. The evaluation of effect of FACA® syrup in vitro on sickling revealed that, FACA® syrup possesses a real antisickling activity. Regarding these results FACA® syrup would be considered as safe in both acute and subacute exposure and could be used in the management of sickle cell diseases.
Keywords: FACA® syrup, oral toxicity, sickle cell anemia, Antisickling activity
Keywords:
FACA® syrup, oral toxicity, sickle cell anemia, Antisickling activityDOI
https://doi.org/10.22270/jddt.v10i5-s.4336References
O.M.S. Stratégie de l’OMS pour la médecine traditionnelle pour 2014-2023. 2013; 72. Available from: http://www.who.int/about/licensing/copyright_form/en/index.html
OMS. Stratégie de l ’ OMS pour la Médecine Traditionnelle pour 2002 – 2005. 2002;78.
WHO. Sickle-Cell Disease: A Strategy For The WHO African Region Report of the Regional Director. 2010.
Cook GC. Manson ’ s Tropical Diseases , 21st Edition PDxMD : Infectious Diseases , Volumes One. 2003; 37:2003.
OMS. Drépanocytose, Rapport du Secrétariat. Cinquante-neuvieme assemblée mondiale de la santé. Point 114 l’ordre du jour provisoire. 2006; 6.
Grosse SD, Odame I, Atrash HK, Amendah DD, Piel FB, Williams TN. Sickle cell disease in Africa: A neglected cause of early childhood mortality [Internet]. Vol. 41, American Journal of Preventive Medicine. Elsevier Inc.; 2011 [cited 2020 Aug 28]. Available from: https://pubmed.ncbi.nlm.nih.gov/22099364/
Meier ER, Miller JL. Sickle cell disease in children [Internet]. Vol. 72, Drugs. NIH Public Access; 2012 [cited 2020 Aug 28]. p. 895–906. Available from: /pmc/articles/PMC3899685/?report=abstract
Guissou IP, Sawadogo M, Sawadogo A, Ouattara A. étude de l’efficacité antidrepanocitaire de gelules faca chez les enfants en milieu hospitalier de Ouagadougou (chn-yo). Pharm Méd trad afro. 1995; 29–36.
Ouattara B, Jansen O, Angenot L, Guissou IP, Frédérich M, Fondu P, et al. Antisickling properties of divanilloylquinic acids isolated from Fagara zanthoxyloides Lam. (Rutaceae). Phytomedicine [Internet]. 2009 Mar [cited 2020 Aug 28]; 16(2–3):125–9. Available from: https://pubmed.ncbi.nlm.nih.gov/19110407/
Ouédraogo GG. Etude de la toxicité d’extraits de poudre d’écorces de racines de Calotropis procera (ait.) R.br. (Apocynaceae), composante du FACA®, phytomédicament utilisé au Burkina Faso. THESE UNIQUE, Dr ès Sci d’Application Pharm Univ Ouagadougou. 2015; 211.
Nikiema JB, Ouattara B, Semde R, Djierro K, Compaore M, Guissou IP, et al. Promotion de la Médecine traditionelle du Burkina Faso : essai de développement d’un Médicament antidrépanocytaire, le Faca. In: african traditional medecine day. 2010. p. 52–7.
Ouedraogo S, Traoré S, Ouédraogo JCW, Koala M, Belemnaba L, Ouédraogo N, et al.
Quality control and standardization of FACA® syrup
. Int J Drug Deliv. 2018; 9(4):101.Ouédraogo JWC, Kini FB, Belemnaba L, Ouédraogo S. Standardisation de la poudre des écorces de racine de Zanthoxylum zanthoxyloides en vue la production d’un phytomédicament antidrépanocytaire pédiatrique. J la Société Ouest-Africaine Chim. 2015;040:24–30.
OECD. OECD/OCDE 423 OECD GUIDELINE FOR TESTING OF CHEMICALS Acute Oral Toxicity-Acute Toxic Class Method [Internet]. 2001 [cited 2019 Aug 10]. Available from: https://ntp.niehs.nih.gov/iccvam/suppdocs/feddocs/oecd/oecd_gl423.pdf
Oecd/Ocde. Lignes directrices de l’ocde pour les essais de produits chimiques-Étude de toxicité orale à dose répétée pendant 28 jours sur les rongeurs. 2008; (11):1–15.
Seck M, Sall C, Gueye PM, Seck I, DiouMl MD, Lembachar Z, et al. Etude de l ’ activité antifalcémiante d ’ extraits de racines de Leptadenia hastata. 2015; (June).
Sawadogo S, Sanou SD, Dabire P, Belemtougri GR, Sawadogo L, Leiris J De, et al. Activité antifalcémiante d ’ extraits de trois plantes médicinales du Bukina Faso : Jatropha curcas , Khaya senegalensis et Dichrostachys cinerea Antisickling activity of extracts of three medicinal plants of Bukina Faso : Jatropha curcas , Khaya senegale. 2017; 11(October):2016–27.
Seck M, Sall C, Gueye P, Seck I, Dioum M, Lembachar Z, et al. Etude de l’activité antifalcémiante d’extraits de racines de Leptadenia hastata Decne. (Asclepiadacae). Int J Biol Chem Sci. 2015 Sep 9; 9(3):1375.
United Nations. Globally Harmonized System of Classification and Labelling of Chemicals (GHS) [Internet]. ST/SG/AC.1. 2017 [cited 2019 Aug 10]. Available from: https://www.unece.org/fileadmin/DAM/trans/danger/publi/ghs/ghs_rev07/English/ST_SG_AC10_30_Rev7e.pdf
Ogwal-okeng JW, Obua C, Anokbonggo WW. Acute toxicity effects of the methanolic extract of Fagara zanthoxyloides ( Lam .) root-bark. 2004;(January).
Kinda PT, Guenn S, Compaor M, Bayala B, Ciobica A, Belemtougri R, et al. Toxicological characterization and central nervous system effects of Calotropis procera Ait . aqueous extracts in mice. 2019; 12(7):329–36.
Ouedraogo GG, Ouedraogo M, Lamien-sanou A, Lompo M, Olga M, Guissou PI. Acute and Subchronic Toxicity Studies of Roots Barks Extracts of Calotropis procera ( Ait .) R . Br Used in the Treatment of Sickle Cell Disease in Burkina Faso. Br J Pharmacol Toxicol. 2013;4(5):194–200.
Ouedraogo GG, Ilboudo S, Ouedraogo N, Ouedraogo S, Diallo D, Guissou PI. Phytochemical study and cardiovascular toxic effects investigation of root barks powder and extracts from calotropis procera (ait.) R.BR. World J Pharm Res World J Pharm Res [Internet]. 2016 [cited 2020 Sep 8];5(9):299–316. Available from: www.wjpr.net
Mukinda JT, Syce JA. Acute and chronic toxicity of the aqueous extract of Artemisia afra in rodents. 2007;112:138–44.
Li X, Luo Y, Wang L, Li Y, Shi Y, Cui Y, et al. Acute and subacute toxicity of ethanol extracts from Salvia przewalskii Maxim in rodents. J Ethnopharmacol [Internet]. 2010; 131(1):110–5. Available from: http://dx.doi.org/10.1016/j.jep.2010.06.012
Pariyani R, Ismail IS, Azam AA, Abas F, Shaari K, Sulaiman MR. Phytochemical Screening and Acute Oral Toxicity Study of Java Tea Leaf Extracts. 2015; 2015.
Nwozo SO, Tijani HA, Oyinloye BE. Toxicological Evaluation of Methanolic Extract of Zanthoxylum zanthozyloide Stem Bark Toxicological Evaluation of Methanolic Extract of Zanthoxylum zanthozyloide Stem Bark. 2011;(January 2011).
DEMBELE S. M. F. Etude pharmacothérapeutique du phytomédicament antidréranocytaire• FACA® : proprietés pharmacologiques chez l’animal et efficacite thérapeutique chez l’enfant drepanocytaire au CHUY O de ouagadougou These. Universite de Ouagadougou; 2001.
Ouédraogo, Moustapha. Etude pharmaco-chimique du macéré aqueux des écorces de racines de calotropis procera Ait (Asclépiadacée) utilisées en phytothérapie de la maladie drépanocytaire au Burkina Faso. 2001.
Published
Abstract Display: 982
PDF Downloads: 894 How to Cite
Issue
Section
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).

.