Download EVALUATION OF HEAVY METALS IN AYURVEDIC MEDICINES

EVALUATION OF HEAVY METALS IN AYURVEDIC
MEDICINES USING X-RAY FLOURESCENCE ANALYSER
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RAJIV GANDHI UNIVERSITY OF HEALTH SCINECES, KARNATAKA
BANGALORE -41
PROFORMA FOR REGISTRATION OF SUBJECT FOR PROJECT WORK
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NAME OF THE CANDIDATE
ADDRESS
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NAME OF INSTITUTION
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COURSE OF STUDY & SUBJECT
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DATE OF ADMISSION TO COURSE
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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
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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.
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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
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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
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Analysis of heavy metals in Ayurvedic medicines using state of art technology “X-ray
fluorescence spectroscopy.”
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Analysis of heavy metals in branded and unbranded Ayurvedic medicines
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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.
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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
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Used as therapeutic agents used for common disorders like diabetes, blood pressure,
anorexia and any other ailment.
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Available as capsules and as powder
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From Ayurvedic pharmacy, small shops & home remedy.
Exclusion Criteria
Ayurvedic medicines
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Liquid, semi solid, contaminated.
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Mixture of two or more medicines
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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
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Student’s ‘t’ test
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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
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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)
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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
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Facilities are available to conduct the study.
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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
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