Ayurvedic formulations containing benzoic and ascorbic acids as additives: benzene formation during storage and impact of additives on quality parameters
Abstract
Objectives
Ayurvedic formulations are becoming the prior choice of people as health care supplements. The increasing demand for these formulations has led to extensive development of Ayurvedic pharmaceutical industries worldwide. The reaction between the preservatives (sodium benzoates and ascorbic acid) used in these formulations could generate benzene. Benzene is classified as class-1 human carcinogen and responsible for various short and long term health effects.
Methods
In this study, 25 formulations (containing ascorbic acid and sodium benzoate) of various manufacturers available as over the counter products were obtained and their benzene content were determined using gas chromatograph with flame ionization detector.
Results
The result showed that 64% of the formulations were free from benzene contamination whereas 36% of formulations were found to be contaminated with benzene. A simple, less time-consuming, economic, and validated gas chromatographic method for estimation of benzene in Ayurvedic formulations was also developed successfully in present study.
Conclusions
The data revealed that the level of benzene was within permissible limits, yet the presence of a carcinogen in the marketed formulations intended for internal use is an alarming situation.
Research funding: None declared.
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
Competing interests: Authors state no conflict of interest.
Informed consent: Informed consent was obtained from all individuals included in this study.
References
1. Chaudhary, A, Singh, N, Dalvi, M, Wele, A. A progressive review of Sandhana kalpana (Biomedical fermentation): an advanced innovative dosage form of ayurveda. Ayu 2011;32:408–17. https://doi.org/10.4103/0974-8520.93925.Search in Google Scholar PubMed PubMed Central
2. Chirag, JP, Tyagi, S, Kanu, JP, Tushar, P, Harnish, KP, Priyanka, HP. Standardization of herbal medicine: a concise review. J Pharma Bio Res 2014;2:97–101.Search in Google Scholar
3. Kumari, R, Kotecha, M. A review on the standardization of herbal medicines. Inter J Pharma Sci Res 2016;7:97–106. https://doi.org/10.7897/2230-8407.07319.Search in Google Scholar
4. Maithani, M, Raturi, R, Sharma, P, Gupta, V, Bansal, P. Elemental impurities in pharmaceutical products adding fuel to the fire. Regul Toxicol Pharmacol 2019;108:104435. https://doi.org/10.1016/j.yrtph.2019.104435.Search in Google Scholar PubMed
5. Mishra, AK, Pillai, KU. Preservatives and their use in ayurvedic pharmaceutics. Anves Ayur Med J 2016;8:520–3.Search in Google Scholar
6. Morsi, RM, El-Tahan, NR, El-Tobgy, K. Probability of benzene forming in Egyptian non-alcohol carbonated soft drinks. Aus J Bas Appl Sci 2012;6:271–8.Search in Google Scholar
7. McNeal, TP, Nyman, PJ, Diachenko, GW, Hollifield, HC. Survey of benzene in foods by using headspace concentration techniques and capillary gas chromatography. J AOAC Inter 1993;76:1213–9. https://doi.org/10.1093/jaoac/76.6.1213.Search in Google Scholar
8. Alviggi, C, Guadagni, R, Conforti, A, Coppola, G, Picarelli, S, De Rosa, P, et al. Association between intrafollicular concentration of benzene and outcome of controlled ovarian stimulation in IVF/ICSI cycles: a pilot study. J Ovar Res 2014;7:67–72. https://doi.org/10.1186/1757-2215-7-67.Search in Google Scholar PubMed PubMed Central
9. Lachenmeier, DW, Steinbrenner, N, Behrends, SL, Reusch, H, Kuballa, T. Benzene contamination in heat-treated carrot products including baby foods. Op Toxicol J 2010;4:39–42. https://doi.org/10.2174/1874340401004010039.Search in Google Scholar
10. Santos, VPSD, Salgado, AD, Torres, AG, Pereira, KS. Benzene as a chemical hazard in processed foods. Inter J Food Sci 2015;1:1–7.10.1155/2015/545640Search in Google Scholar PubMed PubMed Central
11. Yoon, JH, Kwak, WS, Ahn, YS. A brief review of relationship between occupational benzene exposure and hematopoietic cancer. Ann Occup Environ Med 2018;30:1–5. https://doi.org/10.1186/s40557-018-0245-9.Search in Google Scholar PubMed PubMed Central
12. Smith, B, Cadby, P, DiNovi, M, Setzer, RW. Application of the margin of exposure (MoE) approach to substances in food that are genotoxic and carcinogenic: example: Benzene, CAS: 71–43-2. Food Chem Toxicol 2010;48:S49–56. https://doi.org/10.1016/j.fct.2009.10.015.Search in Google Scholar PubMed
13. Andrea, MA, Reddy, K. Health risks associated with benzene exposure in children: a systematic review. Glob Ped Heal 2018;5:1–10.10.1177/2333794X18789275Search in Google Scholar
14. Goldstein, BD. Benzene as a cause of lymphoproliferative disorders. Chemico Bio Interact 2010;184:147–50. https://doi.org/10.1016/j.cbi.2009.12.021.Search in Google Scholar PubMed
15. World Health Organization. Exposure to benzene: a major public health concern. Geneva: World Health Organization, Preventing disease through healthy environments; 2010:p. 1–5.Search in Google Scholar
16. Rappaport, SM, Kim, S, Lan, Q, Li, G, Vermeulen, R, Waidyanatha, S, et al. Human benzene metabolism following occupational and environmental exposures. Chemico Bio Interact 2010;184:189–95. https://doi.org/10.1016/j.cbi.2009.12.017.Search in Google Scholar PubMed PubMed Central
17. Reutman, SR, LeMasters, GK, Knecht, EA, Shukla, R, Lockey, JE, Burroughs, GE, et al. Evidence of reproductive endocrine effects in women with occupational fuel and solvent exposures. Environ Heal Perspect 2002;110:805–11. https://doi.org/10.1289/ehp.02110805.Search in Google Scholar PubMed PubMed Central
18. Mihaich, EM, Borgert, CJ. Hypothesis-driven weight-of-evidence analysis for the endocrine disruption potential of benzene. Regul Toxicol Pharmacol 2018;100:7–15. https://doi.org/10.1016/j.yrtph.2018.09.027.Search in Google Scholar PubMed
19. Mandani, P, Desai, K, Highland, H. Cytotoxic effects of benzene metabolites on human sperm function: an in-vitro study. ISRN Toxicol 2013;1:1–6. https://doi.org/10.1155/2013/397524.Search in Google Scholar PubMed PubMed Central
20. Heshmati, A, Ghadimi, S, Khaneghah, AM, Barba, FJ, Lorenzo, JM, Nazemi, F, et al. Risk assessment of benzene in food samples of Iran’s market. Food Chem Toxicol 2018;114:278–84. https://doi.org/10.1016/j.fct.2018.02.043.Search in Google Scholar PubMed
21. Codex Alimentarius commission. Joint FAO/WHO food standards programme codex committee on contaminants in foods, discussion paper on benzene in soft drinks. Third Session, Food & Agriculture Organization of the United Nations; 2009;1–21.Search in Google Scholar
22. World Health Organization. WHO guidelines for assessing quality of herbal medicines with reference to contaminants and residues. Geneva; 2007:p. 1–173.Search in Google Scholar
23. Kalaiselvan, V, Shah, AK, Patel, FB, Rajasekaran, A. Quality assessment of different marketed brands of Dasamoolaristam, an Ayurvedic formulation. Inter J Ayur Res 2010;1:10–3. https://doi.org/10.4103/0974-7788.59937.Search in Google Scholar PubMed PubMed Central
24. Central Council for Research in Ayurvedic SciencesGeneral guidelines for drug development of ayurvedic formulations, 1New Delhi: Central Council for Research in Ayurvedic Sciences, Ministry of AYUSH, Govt. of India; 2018:p. 1–100.Search in Google Scholar
25. Anon. Avoid the preservatives E211 & E212 in vitamin C rich foods to avoid cancer; 2017. Available from: https://www.change.org/p/fssai-avoid-the-preservatives-e211-e212-in-vitamin-c-rich-foods-to-avoid-cancer [Accessed 8 Oct 2019].Search in Google Scholar
26. Maithani, M, Gupta, V, Bansal, P, Singh, H, Raturi, R. Development of novel ICH compliant method for estimation of ethanol content in traditionally fermented ayurvedic formulations. Cur Trad Med 2019;5:132–9. https://doi.org/10.2174/2215083804666181002094356.Search in Google Scholar
27. Maithani, M, Grover, H, Raturi, R, Gupta, V, Bansal, P. Ethanol content in traditionally fermented ayurvedic formulations: compromised Good Manufacturing Practice regulations–compromised health. Amer J Drug Alco Ab 2019;45:208–16. https://doi.org/10.1080/00952990.2018.1529181.Search in Google Scholar PubMed
28. Cao, XL, Casey, V. Improved method for the determination of benzene in soft drinks at sub-ppb levels. Food Add Cont 2008;25:401–5. https://doi.org/10.1080/02652030701586673.Search in Google Scholar PubMed
29. Kolb, B, Ettre, LS. Static headspace-gas chromatography: theory and practice. New York: John Wiley & Sons; 2006. p. 1–338.10.1002/0471914584Search in Google Scholar
30. Lachenmeier, DW, Reusch, H, Sproll, C, Schoeberl, K, Kuballa, T. Occurrence of benzene as a heat-induced contaminant of carrot juice for babies in a general survey of beverages. Food Add Cont 2008;25:1216–24. https://doi.org/10.1080/02652030802036230.Search in Google Scholar PubMed
31. World Health Organization. Traditional medicine, fact sheet No. 134; 2013. Available from: http://www.who.int/mediacentre/factsheets/fs134/en [Accessed 25 Oct 2017].Search in Google Scholar
© 2020 Walter de Gruyter GmbH, Berlin/Boston
Articles in the same Issue
- Frontmatter
- Reviews
- Endocannabinoids release after Osteopathic Manipulative Treatment. A brief review
- A pervasive scientific overview on mangiferin in the prevention and treatment of various diseases with preclinical and clinical updates
- Clinical trials of homeopathy in urological disorders: a systematic review
- Strategies in traditional Persian medicine to maintain a healthy life in the elderly
- Research articles Basic
- Cytoprotective and antisecretory properties of methanolic extract of Distemonanthus benthamianus (Caesalpiniaceae) stem bark on acute gastric ulcer in rats
- Screening chemical inhibitors for alpha-amylase from leaves extracts of Murraya koenigii (Linn.) and Aegle marmelos L.
- Ayurvedic formulations containing benzoic and ascorbic acids as additives: benzene formation during storage and impact of additives on quality parameters
- High cholesterol diet promotes dysfunction of arginase and cholinergic enzymatic system in rats: ameliorative role of caffeic and chlorogenic acids
- Cytokine and inflammatory mediators are associated with cytotoxic, anti-inflammatory and apoptotic activity of honeybee venom
- Anti-anaemic effect of ethanol leaf extract of Cnidosculus aconitifolius on cyclophosphomide-induced anaemia in rats
- Alterations in histological, biochemical and hematological parameters in Plasmodium berghei NK-65 infected balb/c mice treated with Bridelia ferruginea stem bark extract
- Structural characterization, antioxidant, and antibiofilm activities of Coffea canephora green seeds
- Research articles Clinical
- Safety, efficacy and tolerability of a combination micronutrient and polyherbal preparation (GoutFighterTM) for gout: a single-arm open-label pilot study
- Efficacy of Habbul aas (fruits of Myrtus communis) in menorrhagia: a single blinded randomized standard control study
- Ginger (Zingiber officinale) and turmeric (Curcuma longa L.) supplementation effects on quality of life, body composition, bone mineral density and osteoporosis related biomarkers and micro-RNAs in women with postmenopausal osteoporosis: a study protocol for a randomized controlled clinical trial
- Lithotriptic effect of Safūf Hajar-al Yahūd in patients of Hasat-ul Kilya (Nephrolithiasis) – an open prospective clinical validation trial
- Efficacy of Qurs-e-Gulnar in Ziabetus (type 2 Diabetes Mellitus): a single blind randomized controlled trial
- Immediate effect of Kapalbhathi pranayama on short term heart rate variability (HRV) in healthy volunteers
- Designing and validation of a yoga-based module for obesity with metabolic comorbidities
- A mixed-method randomized feasibility trial evaluating progressive muscle relaxation or autogenic training on depressive symptoms and quality of life in people living with human immunodeficiency virus (HIV) who have depressive symptoms
- Analysis of the bio-psychological characteristics of Sasang typology in Korean preschool children using the ponderal index and the temperament and character inventory
- Complementary and alternative medicine is positively associated with religiousness/spirituality
- Comparison the effects of inhalation and massage aromatherapy with lavender and sweet orange on fatigue in hemodialysis patients: a randomized clinical trial
- Improvement in resilience and stress-related blood markers following ten months yoga practice in Antarctica
- Neutral douche: a hydrotherapeutic tool to manage pain and systemic symptoms in primary dysmenorrhea - a randomised controlled study
- Short Communication
- The effects of omega-3 on the sleep quality of patients with uremic pruritus undergoing hemodialysis: a randomized crossover study
- Case Reports
- Āyuṛveda management of keratosis pilaris – a case report
- Improvement in impaired ocular accommodation by parietal acupoint therapy to relieve neck stiffness: a case report
Articles in the same Issue
- Frontmatter
- Reviews
- Endocannabinoids release after Osteopathic Manipulative Treatment. A brief review
- A pervasive scientific overview on mangiferin in the prevention and treatment of various diseases with preclinical and clinical updates
- Clinical trials of homeopathy in urological disorders: a systematic review
- Strategies in traditional Persian medicine to maintain a healthy life in the elderly
- Research articles Basic
- Cytoprotective and antisecretory properties of methanolic extract of Distemonanthus benthamianus (Caesalpiniaceae) stem bark on acute gastric ulcer in rats
- Screening chemical inhibitors for alpha-amylase from leaves extracts of Murraya koenigii (Linn.) and Aegle marmelos L.
- Ayurvedic formulations containing benzoic and ascorbic acids as additives: benzene formation during storage and impact of additives on quality parameters
- High cholesterol diet promotes dysfunction of arginase and cholinergic enzymatic system in rats: ameliorative role of caffeic and chlorogenic acids
- Cytokine and inflammatory mediators are associated with cytotoxic, anti-inflammatory and apoptotic activity of honeybee venom
- Anti-anaemic effect of ethanol leaf extract of Cnidosculus aconitifolius on cyclophosphomide-induced anaemia in rats
- Alterations in histological, biochemical and hematological parameters in Plasmodium berghei NK-65 infected balb/c mice treated with Bridelia ferruginea stem bark extract
- Structural characterization, antioxidant, and antibiofilm activities of Coffea canephora green seeds
- Research articles Clinical
- Safety, efficacy and tolerability of a combination micronutrient and polyherbal preparation (GoutFighterTM) for gout: a single-arm open-label pilot study
- Efficacy of Habbul aas (fruits of Myrtus communis) in menorrhagia: a single blinded randomized standard control study
- Ginger (Zingiber officinale) and turmeric (Curcuma longa L.) supplementation effects on quality of life, body composition, bone mineral density and osteoporosis related biomarkers and micro-RNAs in women with postmenopausal osteoporosis: a study protocol for a randomized controlled clinical trial
- Lithotriptic effect of Safūf Hajar-al Yahūd in patients of Hasat-ul Kilya (Nephrolithiasis) – an open prospective clinical validation trial
- Efficacy of Qurs-e-Gulnar in Ziabetus (type 2 Diabetes Mellitus): a single blind randomized controlled trial
- Immediate effect of Kapalbhathi pranayama on short term heart rate variability (HRV) in healthy volunteers
- Designing and validation of a yoga-based module for obesity with metabolic comorbidities
- A mixed-method randomized feasibility trial evaluating progressive muscle relaxation or autogenic training on depressive symptoms and quality of life in people living with human immunodeficiency virus (HIV) who have depressive symptoms
- Analysis of the bio-psychological characteristics of Sasang typology in Korean preschool children using the ponderal index and the temperament and character inventory
- Complementary and alternative medicine is positively associated with religiousness/spirituality
- Comparison the effects of inhalation and massage aromatherapy with lavender and sweet orange on fatigue in hemodialysis patients: a randomized clinical trial
- Improvement in resilience and stress-related blood markers following ten months yoga practice in Antarctica
- Neutral douche: a hydrotherapeutic tool to manage pain and systemic symptoms in primary dysmenorrhea - a randomised controlled study
- Short Communication
- The effects of omega-3 on the sleep quality of patients with uremic pruritus undergoing hemodialysis: a randomized crossover study
- Case Reports
- Āyuṛveda management of keratosis pilaris – a case report
- Improvement in impaired ocular accommodation by parietal acupoint therapy to relieve neck stiffness: a case report