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EVALUATION OF HEAVY METALS IN AYURVEDIC MEDICINES USING X-RAY FLOURESCENCE ANALYSER 1 RAJIV GANDHI UNIVERSITY OF HEALTH SCINECES, KARNATAKA BANGALORE -41 PROFORMA FOR REGISTRATION OF SUBJECT FOR PROJECT WORK 1 NAME OF THE CANDIDATE ADDRESS 2 NAME OF INSTITUTION 3 COURSE OF STUDY & SUBJECT 4 DATE OF ADMISSION TO COURSE 5 TITLE SIKHA A.S DEPARTMENT OF BIOCHEMISTRY ST. JOHN’S MEDICAL COLLEGE BANGALORE 34 ST. JOHN’S NATIONAL ACADEMY OF HEALTH SCIENCES M. Sc. MLT BIOCHEMISTRY 05-09-2011 EVALUATION OF HEAVY METALS IN AYURVEDIC MEDICINES USING X-RAY FLOURESCENCE ANALYSER 2 NEED FOR STUDY Ayurveda is a traditional form of medicine which is being used worldwide. As the consumption of ayurvedic medicine has increased, there are reports indicating undesirable side effects due to long term consumption of these medicines without proper advice. The side effects are mainly due to the presence of heavy metals Lead, Arsenic, Mercury, Cadmium etc, in the medicine 3, 4 Many branded and unbranded ayurvedic medicines are available in India for therapeutic and cosmetic uses. Due to unsatisfactory agricultural and cultivation practices relating to the medicinal plants used in preparation of Ayurveda, Siddha and Unani (ASU) and general environmental pollution, the presence of heavy metals above permissible limit there in cannot be ruled out.1, 3-4 Further, medicines are known to contain small amounts of heavy metals owing to their role as active ingredient .Government of India has given a directive to all manufactures of ayurvedic medicine, that all drugs should to be tested for presence of heavy metals in permissible limits before being marketed.1 As many drug manufacturers do not have in-house laboratory facility to test the heavy metal content, many medicines are still sold with higher heavy metal content barring permissible limits. This is also applicable to the unbranded medicines which do not go through the testing protocol .In the interest of public health, it becomes necessary to analyze ayurvedic medicines for the presence of Lead, Arsenic, Mercury, Cadmium and other heavy metals such as Gold, Silver and Tin for possible increased heavy metal concentration in medicines sold as “Quality Medicines”. Thus a need arises to quantify the branded and unbranded ayurvedic medicines for heavy metal content and help the community of the toxicity associated with these medicines through awareness programs. 3 REVIEW OF LITERATURE Ayurveda is a traditional medical system used by majority of Indian population and is used worldwide.2 Ayurvedic medicines are primarily composed of herbs, minerals, metals and animal products.3 These are included in either purely herbal or rasa shastra products. Rasa shastra is an ancient practice where metals like lead, mercury, iron and zinc etc, are processed and added to herbs. Heavy metals are commonly incorporated into ayurvedic preparations as ashes or bhasmas.4 Experts in this field claim that rasa shastra products if adequately prepared are safe for administration and claim that the role of bhasmas is to enhance the herbal product potency to act as catalyst and adjuvant for entry in to the relevant cells.5 The equilibrium of lead, copper, gold, iron, mercury, silver, tin and zinc are seen in Ayurveda as they are essential for normal functioning of the human body and act as an important component of good health.6 Some ayurvedic text acknowledge that these heavy metals and potentially other components of ayurvedic medicines could be associated with toxicity and there is a specific branch within Ayurveda that deals with toxicity known as vishagarvajrodhika tantra. There is often specific procedure recommended to detoxify the metals in Ayurvedic products.7 In India, there are over 12,000 ayurvedic hospitals, colleges and many ayurvedic clinics. Ayurveda is the most widely practiced system. Others such as Siddha and Unani are used in Indian subcontinent.2 Although ayurvedic and other traditional medicines can have health benefits, there are numerous reports of significant adverse effects from these products. The first published case of heavy metal poisoning related to ayurvedic medicines was reported in a patient in UK in 1978.8 Most of the reports of heavy metal poisoning related to ayurvedic and other traditional Indian medicines are of lead poisoning. However, there have also been reports of significant mercury and arsenic poisoning.9 The government of India, however has directed that Ayurvedic products must specify their metal content on the label of products.10 Herbs, minerals and metals are used in the preparation of ayurvedic products. Ayurvedic medicines are widely used by those patients with chronic condition such as arthritis, lung disease and diabetes. The consumption of unbranded ayurvedic medicines as causative factor for the heavy metal poisoning was confirmed by the higher quantity of heavy metals content in these medicines.11 4 Bio Chemical and toxicological effect of Heavy Metals Heavy metals affect majority of organ system in the body. Ayurvedic medicine containing heavy metals can cause an adverse impact on health when taken without proper guidance and the usage of unbranded medicine, over a period of time cause complications like chronic constipation, chest pain, abdominal pain, nausea, vomiting, anorexia, fatigue, parasthesia, etc.12 The generally recognized effect of heavy metals particularly lead and mercury is on CNS causing neuropathy and encephalopathy.13 It is characterized clinically by ataxia, seizures, coma convulsion and is often fatal. While arsenic poisoning is known to cause peripheral neuropathy,14 acute encephalopathy and seizures may develop from concentrated exposure of mercury. Hematological effect of lead is attributed to the combined effect of the inhibition of Hemoglobin synthesis and shortened life span of circulating RBC resulting in anemia. Basophilic stippling of RBC is a feature of lead induced anemia. 15 Arsenic poisoning also causes anemia and leucopenia. 16 Renal insufficiency has been associated with decreased renal clearance of uric acid resulting in an increased risk of gouty arthritis in lead poisoning.16 Renal insufficiency is also reported in arsenic and cadmium poisoning. Lead has been associated with adverse reproductive effect in both males and females. Lead exposure in females is associated with infertility, still birth, premature delivery and malformed birth.17, 18 Decreased semen volume, semen density, count of total mobile and liable sperm has been reported in lead poisoned males.19 OBJECTIVE OF THE STUDY Analysis of heavy metals in Ayurvedic medicines using state of art technology “X-ray fluorescence spectroscopy.” Analysis of heavy metals in branded and unbranded Ayurvedic medicines The outcome of the study will be used to help the general public through awareness programs conducted by National Referral Center for Lead Poisoning in India. 5 MATERIALS AND METHODS Sample Collection Ayurvedic medicines with different brands will be collected from registered Ayurvedic pharmacy. The date of manufacturing, expiry and batch numbers will be recorded. All branded Ayurvedic medicines will be checked for their own quality mark. Unbranded medicines will be collected from the Ayurvedic pharmacy and home remedy Ayurvedic practitioners. All Ayurvedic medicines will be collected in air tight plastic containers from Bangalore and or Kerala. Method of Data Collection Study design : Prospective Duration of Study : 1 year Sample size : Minimum 20 samples Inclusion Criteria Ayurvedic medicines Used as therapeutic agents used for common disorders like diabetes, blood pressure, anorexia and any other ailment. Available as capsules and as powder From Ayurvedic pharmacy, small shops & home remedy. Exclusion Criteria Ayurvedic medicines Liquid, semi solid, contaminated. Mixture of two or more medicines 6 Method of Analysis Analysis of heavy metals using INNOV-X-Analyzer, based on the principle of XRF Spectrophotometry X-ray fluorescence spectrometry is used to identify elements in a substance and quantify the amount of those elements present. An element is identified by its characteristic x-ray emissions, wave length or energy(E). The amount of an element present is quantified by measuring the intensity of its characteristic line. XRF- spectrophotometry ultimately determines the elemental composition of a material in µg/gm. Procedure: All samples of Ayurvedic medicines with appropriate collection methods as mentioned under sample collection are crushed to powder before analysis. The instrument is standardized before testing and the samples are analysed using the alloy analysis mode of instrument..The sample is placed on the top of testing stand. 3 readings are taken at the interval of 30 seconds. 21 elements in Ayurvedic medicines can be detected by this instrument. However, the focus is on the heavy metals causing health effects such as Lead, Mercury, Cadmium, Arsenic, Gold, Silver etc., Statistical Analysis Student’s ‘t’ test 7 REFERENCE 1) Section 33EEB of the drug & cosmetic Act 19940 Govt. of India in the Ministry of Health & Family Welfare, Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha & Homeopathy. 2) Gogaty NJ, Bhatt HA, Dalvi S S, Kshirsagar NA(2002). The use and safety of nonallopathic Indian medicines. Drug safety Vol.25, pp 1005-1019 3) Prpic Magic D, Pizent A, Jurasovic J, Pongracic J, Restek-Sa-marzija N. Lead poisoning associated with the use of metal mineral tomics. J Toxicol Clin Toxicol. 1996;34;417-23 4) A. Raviraja, G.N. Vishal Babu, Anusha sehgal, Robert B Saper, Innocent Jayawardene, Chitra J. Amarasiriwardena, T. Venkatesh. Indian J. clin Biochem 2010 25 (3); 326-329 5) SaperRB, Phillips RS, SehgalA,KhouriN,DavisRB, Paquin J, et al.Lead mercury and arsenic in US- and Indian-manufactured Ayurvedic medicines sold via the internet. JAMA. 2008;300(8):915–23. 6) Thatte, U.M., Rege, N.N., Phatak, S.D. and Dahanukar, S.A. (1993) ‘The flip side of Ayurveda’, Journal of Postgraduate Medicine, Vol. 39, pp.179–182. 7) Chopra, A. and Doiphode, V.V. (2002) ‘Ayurvedic medicine. Core concept, therapeutic principles, and current relevance’, Medical Clinics of North America, Vol. 86, pp.75–89. 8) Brearley, R.L. and Forsythe, A.M. (1978) ‘Lead poisoning from aphrodisiacs: potential hazard in immigrants’, British Medical Journal, Vol. 2, pp.1748-1749. 9) Lynch, E. and Braithwaite, R. (2005) ‘A review of the clinical and toxicological aspects of “traditional” (herbal) medicines adulterated with heavy metals’, Expert Opinion on Drug Safety, Vol. 4, pp.769–778. 10) Section 33P of the drug & cosmetic Act 1940 Government of India in the Ministry of Health & family welfare. 11) Menezes Geraldine D’souza Sunil Herman & Thuppil Venkatesh Lead poisoning as a result of infertility treatment using herbal remedies: Arch Gynecol obset 2007; 275: 279-81 12) Dhanashree Dhaware, Aditi Deshpande, RN Kahandekar, Rohini Chowgule, S V Gangal: Study of lead and arsenic in Ayurvedic medicines. Journal of herbal medicine and toxicology 5(1) 39-46 (2011) 13) Casarett & Doull’s Toxicology The Basic Science of Poisons. Toxic effect of metals 7 th edition 2008 by the Mc Graw-Hill : Page 931 8 14) Becket Ns, Moore JK, Krough J petal Accute encephalopathy due to occupassional exposure to arsenic Br.J.Indian Med 1986;43:66-67 15) S.J.S Flora lead exposure health effects, prevention and treatment : Journal of environmental biology 2002,23(1) 25-41 16) Ford, Delaney, Ling, Erikson Clinical Toxicology: Arsenic, 2001 WB Saunders Company 17) Dsouza HS, Menezes G, Venkatesh T (2002) Fetal lead exposure: encephalopathy in a child. Indian J Clin Biochem 17(1):9-11 18) Angel N.F. and J.P. Lavery: The relationship of blood levels to obstetric outcome. Am.J.Obstet. Gynaecol., 142.40 (1982) 19) Alexander, B.H., H. Checkoway and C. van Netten : Semen quality of men employed at lead smelte. Occup. Environ. Med. 53.411-416 ( 1996) 9 SIGNATURE OF THE STUDENT DR. GERALDINE MENEZES NAME AND DESIGNATION OF THE GUIDE ASSOCIATE PROFESSOR DEPARTMENT OF BIOCHEMISTRY ST. JOHNS MEDICAL COLLEGE BANGALORE REMARKS OF THE GUIDE Facilities are available to conduct the study. Study is feasible and is useful for Indian population. SIGNATURE OF THE GUIDE DR. ANITA R. BIJOOR HEAD OF THE DEPARTMENT PROFESSOR AND HEAD ST. JOHNS MEDICAL COLLEGE DEPARTMENT OF BIO CHEMISTRY REMARKS OF THE HOD SIGNATURE OF THE HOD 10