Qualitative and quantitative assessment of cryptolepis-based herbal formulations within the Accra and Kumasi metropolis in Ghana
DOI:
https://doi.org/10.56511/JIPBS.2017.v4.i01.pp58-65Abstract
Cryptolepis sanguinolenta of the family Asclepiadaceae contains the antimalarial alkaloid cryptolepine. Proliferation of Cryptolepis-based formulations in Ghana calls for pharmacovigilance to improve malaria treatment outcomes. The objective of this study is to qualitatively and quantitatively assess Cryptolepis-based formulations on the Ghanaian market. Fourteen registered brands of Cryptolepis-based aqueous formulations were purchased from pharmacies and herbal shops within the Accra and Kumasi metropolis of Ghana. The brands were coded A to N. Phytochemical, packaging and labeling assessments were performed. Microbial contaminations were assessed using the pour plate method. The cryptolepine content in each sample was determined using reverse phase HPLC and was compared using one way ANOVA followed by Bonferroni post hoc multiple comparison test. Samples were screened for possible antimalarial adulterants such as artemether, lumefantrine, artesunate and amodiaquine. None of the brands met the standard packaging and labeling requirements. Brands B, G and M passed the microbial contamination limit test whilst the rest failed. Glycosides, tannins, saponins, and sterols in addition to the alkaloids were detected. Cryptolepine was present in all brands except E and F. Batch 1 of brand M had the highest cryptolepine content (0.324 ± 0.043 mg/ml). There were significant (P≤0.05) variations in the cryptolepine content of the different batches of brands B, I, M and N. Artemether, lumefantrine and amodiaquine were not detected. Eleven of the fourteen brands gave positive test for artesunate. All the brands were defective in one or more of the basic requirements of pharmaceutical formulations. Eleven brands may have been adulterated with artesunate
Keywords:
malaria, herbal formulations, Cryptolepis sanguinolenta, cryptolepine, HPLCDownloads
References
Calixto JB: Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (phytotherapeutic agents). Brazilian Journal of Medical and Biological Research 2000; 33: 179-189.
Mensah CM and Gyasi RM: Use of Herbal Medicine in the Management of Malaria in the Urban-periphery, Ghana. 2012.
Harkey, RM, Henderson, LGand Gershwin EM: Variability in commercial ginseng products: an analysis of 25 preparations. The American journal of clinical nutrition 2001; 73(6): 1101-1106.
Boye, GL and Ampofo, O: Clinical uses of Crytolepis Sanguinolenta (Asclepiadaceae). Proceedings of the First International seminar on Cryptolepine. University of Science and Technology, Kumasi-Ghana, University Press: 37-40.
Boakye-Yiadom K and Heman-Ackah SM: Cryptolepine hydrochloride effect on Staphylococcus aureus. Journal of Pharmaceutical Sciences 1979; 68(12): 1510-1514.
Cimanga K, De Bruyne T, Pieters L, Vlietinck AJ and Turger CA: In Vitro and in Vivo Antiplasmodial Activity of Cryptolepine and Related Alkaloids from Cryptolepis sanguinolenta. J Nat Prod 1997; 60(7): 688691.
Kirby GC, Paine A, Warhust C, Noamese K and Phillison D: In vitro and in vivo antimalarial activity of cryptolepine, a plant-derived indoloquinoline. Phytother Res 1995; 9(5): 359-363.
Wright CW, Phillipson JD, Awe SO, Kirby GC, Warhurst DC, QuetinLeclercq J and Angenot L: Antimalarial Activity of Cryptolepine and Some Other Anhydronium Bases. Phytother Res 1996; 10(4): 361-363.
Wright CW, Addae-Kyereme J, Breen AG, Brown JE, Cox MF, Croft SL and Pollet PL: Synthesis and Evaluation of Cryptolepine Analogues for Their Potential as New Antimalarial Agents. J Med Chem 2001; 44(19): 3187-3194.
Seville S, Roger MP, Steven DS and Wright CW: Synthesis of cryptolepine analogues as potential bioreducible anticancer agents. Bioorganic & Medicinal Chemistry, 2007; 15(19): p. 6353-6360.
Onyeibor O, Croft SL, Dodson HI, Feiz-Haddad M, Kendrick H, Millington NJ and Wright CW: Synthesis of Some Cryptolepine Analogues, Assessment of Their Antimalarial and Cytotoxic Activities, and Consideration of Their Antimalarial Mode of Action. J Med Chem 2005; 48(7): 2701-2709.
Kuntworbe N and Al-Kassas R: Design and in vitro haemolytic evaluation of cryptolepine hydrochloride-loaded gelatine nanoparticles as a novel approach for the treatment of malaria. AAPS PharmSciTech 2012; 13(2).
Singh M, Singh MP and Ablordeppey S: In Vitro Studies with Liposomal Cryptolepine. Drug Development and Industrial Pharmacy 1996; 22(4): 377-381.
Ansah C, Khan A, and Gooderham NJ: In vitro genotoxicity of the West African anti-malarial herbal Cryptolepis sanguinolenta and its major alkaloid cryptolepine.Toxicology 2005; 208(1): 141-147.
Bonjean K, De Pauw-Gillet MC, Defresne MP, Colson P, Houssier C, Dassonneville L, Bailly C, Greimers R, Wright C, Quetin-Leclerq J, Tits M and Angenot L: The DNA Intercalating Alkaloid Cryptolepine Interferes with Topoisomerase II and Inhibits Primarily DNA Synthesis in B16 Melanoma Cells. Biochemistry 1998; 37(15):5136-5146.
Lisgarten JN, Coll M, Portugal J, Wright CW and Aymami J: The antimalarial and cytotoxic drug cryptolepine intercalates into DNA at cytosine-cytosine sites. Nat Struct Mol Biol. 2001; 9(1): 57-60.
Drew A and Myers S: Safety issues in herbal medicine: implications for the health professions. The Medical Journal of Australia 1997; 166(10): 538-554.
Chan K: Some aspects of toxic contaminants in herbal medicines. Chemosphere 2003; 52(9): 1361-1371.
Alwakeel S:Microbial and heavy metals contamination of herbal medicines. Research Journal of Microbiology 2008; 3(12): 683-691.
Kalaiselvan V, Kalaiselvan V, Ankur KS, Falgun BP, Chainesh NS, Kalaivani M and Rajasekaran A:Quality assessment of different marketed brands of Dasamoolaristam, an Ayurvedic formulation. International journal of Ayurveda research, 2010. 1(1): p. 10.
Lee SS, Zhang WU and Li Y:The antimicrobial potential of 14 natural herbal dentifrices: Results of an in vitro diffusion method study. The Journal of the American Dental Association 2004; 135(8): 1133-1141.
Abba D, Inabo HI, Yakubu SE and Olonitola O:Contamination of herbal medicinal products marketed in Kaduna metropolis with selected pathogenic bacteria. African Journal of Traditional, Complementary and Alternative Medicines, 2009. 6(1).
Baratta F, Germano A and Brusa P: Diffusion of counterfeit drugs in developing countries and stability of galenics stored for months under different conditions of temperature and relative humidity. Croatian medical journal 2012; 53(2): 173-184.
Bate R, Jensen P, Hess K, Mooney L and Milligan J: Substandard and falsified anti-tuberculosis drugs: a preliminary field analysis. The international journal of tuberculosis and lung disease 2013; 17(3): 308311.
Uchiyama N, Kikura-hanajiri R, Ogata J and Goda Y: Chemical analysis of synthetic cannabinoids as designer drugs in herbal products. Forensic Science International 2010; 198(1 – 3): 31-38.
Kuntworbe N, Martini N, Brimble M, Alany GR and Al-Kassas R: Isolation and development of a HPLC method for the detection and quantification of cryptolepine and its application in the determination of the total cryptolepine content in the root powder of Cryptolepis sanguinolenta. Pharmacology and Pharmacy 2012; 3(3):263-270.
Wang RY and Wand Y: Beyond accuracy: What data quality means to data consumers. Journal of management information systems 1996; 12(4): 5-34.
Trease GE and Evans WC: Textbook of Pharmacognosy.12 ed. 1983; Tindall: London.
Kumar, EVKS, Etukala JR and Ablordeppey SY: Indolo[3,2-b]quinolines: Synthesis, biological evaluation and structure activity-relationships. MiniReviews in Medicinal Chemistry 2008; 8: 538-554.
Arun R and Smith AA: Simultaneous HPLC-UV method for the estimation of artemether and lumefantrine in tablet dosage form. Int J Pharm Biomed Res 2011; 2(3): 201-5.
César, IdC, Andrade Nogueira FH and Antônio Pianetti G: Simultaneous determination of artemether and lumefantrine in fixed dose combination tablets by HPLC with UV detection. Journal of Pharmaceutical and Biomedical Analysis 2008; 48(3): 951-954.
WHO. Substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC) medical products. 2012.
Bayor MT, Kipo SL and Ofori-Kwakye K: The accuracy and quality of household spoons and enclosed dosing devices used in the administration of oral liquid medications in Ghana. International Journal of Pharmacy and Pharmaceutical Sciences 2010; 2(1):150-153.
Kuntworbe N., Alany RG, Brimble M and Al-kassas R: Determination of pKa and forced degradation of the indoloquinoline antimalarial compound cryptolepine hydrochloride. Pharmaceutical Development and Technology 2013; 18(4): 866-876.
Ablordeppey SY, Fan PC, Clark AM and Nimrod A: Probing the N-5 Region of the Indoloquinoline Alkaloid, Cryptolepine for Anticryptococcal Activity. Bioorg Med Chem. 1999; 7(2): p. 343-349.
Tay SCK, Dankwa K, Gbedema SY and Archibald A: In vivo antimalarial activity evaluation of two crytolepis sanguinolenta based herbal decoctions. Ethnopharmacolgy 2011; 1: 2-5.
Ansah C and Gooderman JN: The popular herbal antimalarial, extract of Cryptolepis sanguinolenta, is potently cytotoxic. Toxicological Sciences 2002; 70(2), 245-251.
Published
How to Cite
Issue
Section
Copyright (c) 2017 Adelaide Mensah, Noble Kuntworbe, Raphael Johnson, Kwabena Ofori-Kwakye
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
Journal of Innovations in Pharmaceutical and Biological Sciences is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License. Based on a work at