Recent Trends in the Usage of Herbo-Mineral Formulations in ... - IJPI
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INTERNATIONAL JOURNAL OF<br />
REVIEW ARTICLE<br />
PHARMACEUTICAL INNOVATIONS ISSN 2249-1031<br />
<strong>Recent</strong> <strong>Trends</strong> <strong>in</strong> <strong>the</strong> <strong>Usage</strong> <strong>of</strong> <strong>Herbo</strong>-M<strong>in</strong>eral <strong>Formulations</strong> <strong>in</strong><br />
Healthcare System<br />
Joshi Nirali. B. * 1 , and Shankar M. B. 2<br />
1. Shri Jagdish Prasad Jhabarmal Tibrewala University, Vidyanagari, Jhunjhunu, Rajasthan.<br />
2. Shivam Pharmaceutical studies and research centre, Valasan, Anand – 388 326<br />
ABSTRACT:<br />
Ayurveda has earth-shatter<strong>in</strong>g <strong>in</strong> audience <strong>of</strong> worldwide on virtue <strong>of</strong> its<br />
holistic approach <strong>of</strong> life and its fewer side effects. Ayurvedic herbal and<br />
herbo-m<strong>in</strong>eral preparations are used for <strong>the</strong> treatment <strong>of</strong> chronic and<br />
degenerative diseases without any side -effect. <strong>Herbo</strong>-m<strong>in</strong>eral formulation<br />
uses herbs, m<strong>in</strong>erals or metals as bhasmas for chronic disorders and proved<br />
its effectiveness. The present work is an attempt to emphasis on <strong>the</strong> benefits<br />
and problems associated with it.<br />
Key words: Ayurveda, Bhasma, Heavy metals, <strong>Herbo</strong>-m<strong>in</strong>eral, Rasayana<br />
Tantra, S<strong>in</strong>doora<br />
INTRODUCTION:<br />
Ayurveda is a holistic eternal<br />
heal<strong>in</strong>g science that existed <strong>in</strong> <strong>the</strong><br />
universal consciousness. It is a<br />
science that deals not only with<br />
treatment <strong>of</strong> some diseases but is a<br />
complete way <strong>of</strong> life (1 ) . Ayurveda<br />
was first perceived by Brahma who<br />
<strong>the</strong>n taught it to Daksha-Prajapati<br />
followed by Aswani-kumars.<br />
Knowledge <strong>of</strong> Ayurveda <strong>in</strong>dicates<br />
<strong>the</strong> appropriate and <strong>in</strong>appropriate,<br />
happy or sorrowful condition <strong>of</strong><br />
liv<strong>in</strong>g, what is auspicious or<br />
<strong>in</strong>auspicious for prolonged<br />
existence as well as measure <strong>of</strong> life<br />
(2 ) .<br />
<strong>Formulations</strong> o f Ayurveda are<br />
herbal, m<strong>in</strong>eral, metal and animal<br />
orig<strong>in</strong>, which are processed<br />
pharmaceutically for <strong>the</strong>ir<br />
<strong>the</strong>rapeutic effects. In today‟s<br />
scenario 80% <strong>of</strong> world‟s population<br />
depends on herbal drugs. Accord<strong>in</strong>g<br />
to WHO, Ayurvedic medic<strong>in</strong>es<br />
come under traditional medic<strong>in</strong>es<br />
and refers to health practices,<br />
approaches knowledge and beliefs<br />
<strong>in</strong>corporat<strong>in</strong>g plant, animal and<br />
m<strong>in</strong>eral based medic<strong>in</strong>es, spiritual<br />
<strong>the</strong>rapies, manual techniques and<br />
*Correspond<strong>in</strong>g Author<br />
Joshi Nirali. B.<br />
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exercises (Yoga and Pranayam),<br />
applied s<strong>in</strong>gularly (Herb) or <strong>in</strong><br />
comb<strong>in</strong>ation (Polyherb) to treat,<br />
diagnose and prevent illnesses or<br />
ma<strong>in</strong>ta<strong>in</strong> well-be<strong>in</strong>gs (3 ) .<br />
Despite <strong>of</strong> tremendous advancement<br />
<strong>in</strong> Allopathic system <strong>of</strong> medic<strong>in</strong>es,<br />
<strong>the</strong>re are many areas <strong>in</strong> which<br />
allopathic medic<strong>in</strong>es have failed to<br />
prove its effectiveness. Ma<strong>in</strong><br />
drawback <strong>of</strong> allopathic system is its<br />
side effects, high cost <strong>of</strong> drugs, and<br />
lack <strong>of</strong> curative treatment for<br />
chronic diseases and reoccurrence<br />
<strong>of</strong> disease after stoppage <strong>of</strong><br />
medication. People are los<strong>in</strong>g <strong>the</strong>ir<br />
faith towards allopat hic medic<strong>in</strong>es<br />
and go<strong>in</strong>g towards <strong>the</strong> use <strong>of</strong><br />
traditional medic<strong>in</strong>es such as<br />
Ayurveda, Unani, Sidha and<br />
Naturopathy. As per <strong>the</strong> WHO,<br />
about three-quarters <strong>of</strong> <strong>the</strong> world‟s<br />
population currently use herbs and<br />
o<strong>the</strong>r forms <strong>of</strong> traditional<br />
medic<strong>in</strong>es to treat <strong>the</strong>ir diseases.<br />
Herbal products are natural and<br />
people believe it as a safe medic<strong>in</strong>e<br />
(4 ) .<br />
In recent past <strong>the</strong>re are occurrences<br />
<strong>of</strong> some doubt on safety and<br />
efficacy <strong>of</strong> herbal formulations as<br />
it is marked as a dietary<br />
supplement and <strong>the</strong>y are regulated<br />
under <strong>the</strong> Dietar y Supplement<br />
Health and Education Act<br />
(DSHEA), which does not require<br />
pro<strong>of</strong> <strong>of</strong> safety and efficacy. Herbal<br />
products can be as toxic as or even<br />
more toxic than prescription<br />
medic<strong>in</strong>es. Due to wrong<br />
Volume 3, Issue 3, May − June 2013<br />
<strong>in</strong>terpretation and question <strong>of</strong><br />
safety and efficacy <strong>of</strong> <strong>the</strong> product,<br />
people are afraid <strong>of</strong> us<strong>in</strong>g herbal<br />
medic<strong>in</strong>es. Therefore, it is<br />
necessary to access <strong>the</strong> quality <strong>of</strong><br />
drugs based on <strong>the</strong> active<br />
<strong>in</strong>gredient and safety and efficacy<br />
<strong>of</strong> <strong>the</strong> product as per <strong>the</strong> WHO<br />
guidel<strong>in</strong>es for formulation and raw<br />
material. Standardization <strong>of</strong> herbal<br />
drugs <strong>in</strong>cludes au<strong>the</strong>ntication <strong>of</strong> its<br />
identity and determ<strong>in</strong>ation <strong>of</strong> its<br />
quality and purity. Standardization<br />
<strong>of</strong> herbal formulation is vital and<br />
need broader considerations as <strong>the</strong>y<br />
are developed at time <strong>of</strong> limited<br />
access to technologically variable<br />
norms <strong>of</strong> standardization (5 ) .<br />
Herbal <strong>in</strong>dustry due to its holistic<br />
approach towards life and fewer<br />
side effects made great pace <strong>in</strong><br />
India, with <strong>the</strong> co-operation<br />
between drug regulatory<br />
authorities, scientists and<br />
<strong>in</strong>dustries. Correct recognition <strong>of</strong><br />
raw material is necessary for<br />
avoid<strong>in</strong>g adulteration and to make<br />
it commercially available.<br />
Problems Associated with<br />
Ayurvedic Formulation<br />
Ayurveda is one <strong>of</strong> <strong>the</strong> world‟s<br />
oldest traditional medic<strong>in</strong>al systems<br />
and is experienc<strong>in</strong>g revitalization<br />
among <strong>the</strong> consumers throughout <strong>the</strong><br />
word. However <strong>the</strong> major drawback<br />
associated with Ayurveda is <strong>the</strong> lack<br />
<strong>of</strong> evidence based on its standard<br />
pr<strong>of</strong>ile and quality and safety<br />
aspects <strong>of</strong> Ayurvedic formulations.<br />
There is a lack <strong>of</strong> data support<strong>in</strong>g<br />
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<strong>the</strong> efficacy <strong>of</strong> cl<strong>in</strong>ical trials <strong>in</strong><br />
traditional medic<strong>in</strong>es. O<strong>the</strong>r major<br />
problem associated with Ayurvedic<br />
formulation is <strong>the</strong> loss <strong>of</strong> genetic<br />
biodiversity or risk <strong>of</strong> annih ilation<br />
(6 ) .<br />
Heavy metal (HM) toxicity is a<br />
major safety issue <strong>in</strong> Ayurvedic<br />
formulations and it is essential to<br />
evaluate <strong>the</strong>m for <strong>the</strong>ir content.<br />
Table-1 provides data <strong>of</strong> Ayurvedic<br />
formulations conta<strong>in</strong><strong>in</strong>g heavy<br />
metals (Lead, Mercury, and/or<br />
Arsenic)<br />
(7 ) . Ayurvedic literature<br />
emphasizes <strong>the</strong> use <strong>of</strong> heavy metals<br />
<strong>in</strong> <strong>the</strong>ir formulation due to <strong>the</strong>ir<br />
particular biological properties for<br />
cur<strong>in</strong>g. Ayurveda has described<br />
specific physiochemical processes<br />
like sublimation, heat<strong>in</strong>g etc to<br />
detoxify <strong>the</strong> metals and to avoid its<br />
toxicity Heavy metals <strong>in</strong> Ayurvedic<br />
medic<strong>in</strong>es <strong>in</strong>clude not only lead and<br />
mercury but o<strong>the</strong>r metals such as<br />
chromium, iron, z<strong>in</strong>c, nickel,<br />
cadmium, arsenic and tungsten.<br />
Amount <strong>of</strong> heavy metals and trace<br />
elements <strong>in</strong> Ayurvedic preparation<br />
depends on <strong>the</strong> geographical<br />
location, vary<strong>in</strong>g accord<strong>in</strong>g to <strong>the</strong><br />
quality <strong>of</strong> <strong>the</strong> soil, water or air<br />
pollution (8 ) .<br />
The American medical research<br />
community has sounded a heavy<br />
metal warn<strong>in</strong>g aga<strong>in</strong>st Ayurvedic<br />
cures. Herbal products from <strong>the</strong><br />
Indian system <strong>of</strong> medic<strong>in</strong>e sold <strong>in</strong><br />
<strong>the</strong> US conta<strong>in</strong> dangerous levels <strong>of</strong><br />
lead, mercury & arsenic<br />
(9 ) .<br />
Environmental impact <strong>of</strong> heavy<br />
metals (1 0 , 1 1 ) such as Cd, Pb, Hg<br />
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and as it causes serious concern on<br />
<strong>the</strong> health <strong>of</strong> <strong>in</strong>dividuals. In Japan,<br />
Itai-itai disease (1 2 ) and M<strong>in</strong>amata<br />
disease (1 3 ) are caused due to <strong>the</strong><br />
consumption <strong>of</strong> rice conta<strong>in</strong><strong>in</strong>g Cd<br />
and eat<strong>in</strong>g methyl mercury<br />
contam<strong>in</strong>ated fish respectively.<br />
Table-2 gives <strong>in</strong>formation about<br />
most important disaster occurred<br />
with heavy metals (1 4 ) .<br />
Current levels <strong>of</strong> toxic metals <strong>in</strong><br />
some environmental compartments<br />
may be high enough to constitute a<br />
threat to human health. Table-3<br />
provides data <strong>of</strong> global emission <strong>of</strong><br />
trace metals <strong>in</strong>to atmosphere, water<br />
and soil. Environmental exposure<br />
to low levels <strong>of</strong> lead has been<br />
allied with a wide range <strong>of</strong><br />
metabolic disorders and<br />
neuropsychological deficiencies.<br />
Toxicity <strong>of</strong> lead at metabolic and<br />
cellular level <strong>in</strong> asymptomatic<br />
children <strong>in</strong>clude<br />
Impairments <strong>in</strong> hemoglob<strong>in</strong>,<br />
vitam<strong>in</strong> D and red blood cell<br />
nucleotide metabolism,<br />
Trepidations <strong>of</strong> calcium<br />
homeostasis <strong>in</strong> <strong>the</strong><br />
hepatocytes, bone cells and<br />
bra<strong>in</strong> cells,<br />
Neurological damage<br />
Dangerous level <strong>of</strong> cadmium <strong>in</strong><br />
environment leads to <strong>in</strong>toxication<br />
<strong>of</strong> <strong>the</strong> kidney like tubular<br />
prote<strong>in</strong>uria ad renal dysfunction.<br />
High amount <strong>of</strong> arsenic <strong>in</strong><br />
environment contam<strong>in</strong>ates dr<strong>in</strong>k<strong>in</strong>g<br />
water and causes sk<strong>in</strong> cancer,<br />
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peripheral vascular disorders<br />
(known as black foot disease),<br />
hyper-pigmentation and keratosis<br />
(1 5 ) . Table-4 provides data <strong>of</strong> most<br />
commonly used metals, its toxic<br />
effect on human and <strong>the</strong>ir treatment<br />
(1 6 ) .<br />
Medic<strong>in</strong>al plants grows <strong>in</strong> nature<br />
can accumulate heavy metals at<br />
certa<strong>in</strong> extent which depends on its<br />
<strong>in</strong>dividual properties and <strong>the</strong><br />
concentration <strong>of</strong> HM <strong>in</strong> soil, air<br />
and water<br />
(1 7 ) . Heavy metal<br />
contam<strong>in</strong>ation is due to accidental<br />
contam<strong>in</strong>ation<br />
dur<strong>in</strong>g<br />
manufactur<strong>in</strong>g process such as<br />
gr<strong>in</strong>d<strong>in</strong>g, use <strong>of</strong> lead releas<strong>in</strong>g<br />
equipments or o<strong>the</strong>r manufactur<strong>in</strong>g<br />
utensils (1 8 ) . Due to its hazardous<br />
effect, heavy metal content <strong>in</strong><br />
plants and foodstuff must be<br />
limited and GMPs procedures<br />
should be implemented dur<strong>in</strong>g<br />
manufactur<strong>in</strong>g <strong>of</strong> Ayurvedic<br />
formulation (1 9 ) .<br />
Environment factors can be<br />
controlled by implement<strong>in</strong>g<br />
standard operat<strong>in</strong>g procedures<br />
(SOP) lead<strong>in</strong>g to Good Agricultural<br />
Practice (GAP), Good Laboratory<br />
Practice (GLP), Good Supply<br />
Practice (GSP) and Good<br />
Manufactur<strong>in</strong>g Practice (GMP) for<br />
produc<strong>in</strong>g medic<strong>in</strong>al products from<br />
herbal or natural sources. The<br />
public belief that herbal and natural<br />
products are safer than syn<strong>the</strong>tic<br />
medic<strong>in</strong>es can only be ascerta<strong>in</strong>ed<br />
by impos<strong>in</strong>g regulatory standards<br />
on herbal products that should be<br />
Volume 3, Issue 3, May − June 2013<br />
manufactured us<strong>in</strong>g Good Practices<br />
(2 0 ) . .<br />
Benefits <strong>of</strong> <strong>Herbo</strong>-M<strong>in</strong>eral<br />
<strong>Formulations</strong><br />
<strong>Herbo</strong> m<strong>in</strong>eral formulation uses <strong>the</strong><br />
metals and m<strong>in</strong>erals for chronic<br />
disorders <strong>in</strong> different comb<strong>in</strong>ations,<br />
dosage forms and at various levels<br />
<strong>of</strong> purities. Hence it is very<br />
essential to prepare it <strong>in</strong> a proper<br />
way. As per <strong>the</strong> reported data, <strong>the</strong>re<br />
are so many herbo-m<strong>in</strong>eral<br />
formulations available <strong>in</strong> market<br />
which is useful <strong>in</strong> anemia, diabetes,<br />
cancer, liver diseases, sk<strong>in</strong> diseases<br />
etc. Table-5 shows <strong>the</strong> list <strong>of</strong><br />
herbo-m<strong>in</strong>eral formulation and its<br />
uses <strong>in</strong> common diseases as per<br />
WHO guidel<strong>in</strong>es – Traditional<br />
medic<strong>in</strong>es <strong>in</strong> Asia (2 1 ) .<br />
Prakash et al (2 2 ) reported Prak-20<br />
(judicious comb<strong>in</strong>ation <strong>of</strong> n<strong>in</strong>eteen<br />
herbs and Mandoor Bhasma) that is<br />
a potent hepato-protective herbom<strong>in</strong>eral<br />
formulation used <strong>in</strong><br />
treatment <strong>of</strong> liver ailments <strong>in</strong> CCl 4<br />
<strong>in</strong>duced toxicity <strong>in</strong> rats. Prak -20<br />
treated animals had m<strong>in</strong>imum<br />
necrotic changes after seven day<br />
treatment and fur<strong>the</strong>r studies are<br />
required to understand its<br />
mechanism <strong>of</strong> action.<br />
Chronic urticaria (Refractory sk<strong>in</strong><br />
diseases) <strong>of</strong>ten creates a<br />
<strong>the</strong>rapeutic challenge. Herbal<br />
treatment is ga<strong>in</strong><strong>in</strong>g popularity <strong>in</strong><br />
<strong>the</strong> treatment <strong>of</strong> chronic urticaria.<br />
Azad Hussa<strong>in</strong> et al (2 3 ) has reported<br />
that Unani herbo-m<strong>in</strong>eral<br />
formulation is effective and safe<br />
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for <strong>the</strong> treatment <strong>of</strong> chronic<br />
urticaria. It has produced<br />
significant effect on itch<strong>in</strong>g,<br />
wheals, and ery<strong>the</strong>ma without<br />
caus<strong>in</strong>g any untoward effect or<br />
adverse reactions.<br />
Scabies (Sk<strong>in</strong> diseases) is very<br />
common sk<strong>in</strong> disease found <strong>in</strong><br />
urban population <strong>of</strong> Gadap town<br />
area or Karachi, Pakistan. Sultan<br />
Ayaz et al (2 4 ) has expla<strong>in</strong>ed <strong>the</strong><br />
safety and efficacy <strong>of</strong> herbal coded<br />
medic<strong>in</strong>e, ScaNeem (Herbal coded<br />
medic<strong>in</strong>e), for <strong>the</strong> treatment <strong>of</strong><br />
scabies. The test drug was found to<br />
be an economical, safe and<br />
effective <strong>in</strong> treatment <strong>of</strong> scabies.<br />
Infertility is a very common<br />
medical problem associated with<br />
male person. Rajeev Kumar et at<br />
(2 5 )<br />
has reported <strong>the</strong> use <strong>of</strong> herbo -<br />
m<strong>in</strong>eral supplement – Addyzoa®<br />
(Charak Pharmaceuticals, Mumbai<br />
India conta<strong>in</strong>s Withania somnifera<br />
and Emblica <strong>of</strong>fic<strong>in</strong>alis as its<br />
pr<strong>in</strong>cipal constituent) <strong>in</strong> men with<br />
idiopathic<br />
oligoas<strong>the</strong>noteratospermia (iOATs).<br />
The study concluded that treatment<br />
with Addyzoa is effective <strong>in</strong><br />
improv<strong>in</strong>g <strong>the</strong> semen quality by<br />
<strong>in</strong>creas<strong>in</strong>g <strong>the</strong> sperm count and<br />
sperm motility <strong>in</strong> men with iOATs<br />
after 3 months <strong>of</strong> <strong>the</strong>rapy. There<br />
was no change <strong>in</strong> <strong>the</strong> sperm<br />
concentrations, ROS, DFI or TAD<br />
levels.<br />
Ajit vaze (2 6 ) has described <strong>the</strong> use<br />
<strong>of</strong> Addyzoa herbo-m<strong>in</strong>eral<br />
formulation <strong>in</strong> oligospermia <strong>in</strong><br />
comparison with Ubiqu<strong>in</strong>one<br />
Volume 3, Issue 3, May − June 2013<br />
(Coenzyme Q 10). A double-bl<strong>in</strong>d,<br />
randomized controlled trial was<br />
conducted and study concluded that<br />
treatment with Addyzoa is effective<br />
<strong>in</strong> improv<strong>in</strong>g semen quality by<br />
<strong>in</strong>creas<strong>in</strong>g <strong>the</strong> sperm count and<br />
sperm motilit y. The results are<br />
comparable with that <strong>of</strong><br />
Ubiqu<strong>in</strong>one on semen parameters.<br />
Lauha bhasma is <strong>the</strong> most widely<br />
used herbo-m<strong>in</strong>eral formulation<br />
used <strong>in</strong> iron deficiency anemia.<br />
Verma P. R. P. and Prasad (2 7 ) have<br />
reported <strong>the</strong> use <strong>of</strong> lauha bahsma <strong>in</strong><br />
anemia. It is better absorbed <strong>in</strong> GIT<br />
and devoid <strong>of</strong> <strong>the</strong> usual side effects<br />
associated with adm<strong>in</strong>istration <strong>of</strong><br />
<strong>the</strong> allopathic iron preparation.<br />
Pattonder R. K. et al<br />
(2 8 )<br />
has<br />
reported <strong>the</strong> standardization and<br />
quality control <strong>of</strong> herbo -m<strong>in</strong>eral<br />
drug Agnimantha Bhavita<br />
Shilajatu- ABS (conta<strong>in</strong>s<br />
Agnimantha and Shilajatu) and<br />
Trivrit Yukta Navaka Guggulu-<br />
TYNG (conta<strong>in</strong>s Shunthi, Maricha,<br />
Pippali, Haritaki, Vibhitaki,<br />
Amalaki, Chitrak, Nagarmotha,<br />
Vayavidanga, Suddha Gugguluand<br />
Trivrita). Both ABS and TYNG<br />
were prepared us<strong>in</strong>g au<strong>the</strong>ntic raw<br />
materials and subjected for<br />
physicochemical analysis which<br />
provides objective parameters to<br />
fix up <strong>the</strong> standards for quality<br />
control <strong>of</strong> f<strong>in</strong>ished drugs.<br />
Pawar R. K. and et al<br />
(2 9 )<br />
has<br />
reported <strong>the</strong> physic-chemical<br />
standardization and development <strong>of</strong><br />
HPTLC method for <strong>the</strong><br />
determ<strong>in</strong>ation <strong>of</strong> Plumbag<strong>in</strong> <strong>in</strong><br />
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Kalmegh Navayasa Loha. The<br />
proposed HPLC method is simple,<br />
rapid, accurate, reproducible,<br />
selective and economic and can be<br />
used for rout<strong>in</strong>e quality control<br />
analysis <strong>of</strong> Kalmegh Navayasa loha<br />
powder.<br />
<strong>Herbo</strong>-m<strong>in</strong>eral formulation showed<br />
remarkable improvement <strong>in</strong> quality<br />
<strong>of</strong> life <strong>of</strong> various cancer patients<br />
who have been found to be<br />
refractory or poor responders to<br />
modern chemo<strong>the</strong>rapy and radiation<br />
treatment. Jayawardhane N. D. N.<br />
et al (3 0 ) has stated herbo-m<strong>in</strong>eral<br />
treatment as an adjuvant <strong>in</strong> <strong>the</strong><br />
treatment <strong>of</strong> Hepatocellular<br />
carc<strong>in</strong>oma (HCC) patient. <strong>Herbo</strong> -<br />
m<strong>in</strong>eral formulations (Hemabhraka,<br />
Tamra S<strong>in</strong>doora, Vanda Bhasma,<br />
Manikya pisti etc) are safe, cheap<br />
and effective <strong>in</strong> management <strong>of</strong><br />
HCC and have developed a new<br />
cl<strong>in</strong>ical application <strong>in</strong> treatment <strong>of</strong><br />
Cancer.<br />
Saba Sheikh et al (3 1 ) has reported a<br />
novel herbo-m<strong>in</strong>eral formulation<br />
Las 01 (which conta<strong>in</strong>s a number <strong>of</strong><br />
herbs and different types <strong>of</strong><br />
<strong>in</strong>organic m<strong>in</strong>erals like mercury),<br />
to be effective as a potent<br />
anticancer drug <strong>in</strong> <strong>the</strong> human cell<br />
l<strong>in</strong>es, <strong>the</strong> MCF-7 and Hela cancer<br />
cell l<strong>in</strong>es. It is devoid <strong>of</strong> toxicity<br />
both <strong>in</strong> animals as well as human<br />
which is <strong>the</strong> ma<strong>in</strong> drawback <strong>of</strong><br />
chemo<strong>the</strong>rapeutic agents used <strong>in</strong><br />
modern system <strong>of</strong> medic<strong>in</strong>e.<br />
Badari Nath and Madhusudhana<br />
Chetty (3 2 ) have studied <strong>the</strong> effect<br />
<strong>of</strong> a herbo-m<strong>in</strong>eral tablet<br />
Volume 3, Issue 3, May − June 2013<br />
(conta<strong>in</strong><strong>in</strong>g green tea aqueous<br />
extract and Sodium selenite) for<br />
chemoprevention <strong>of</strong> lung cancer <strong>in</strong><br />
tobacco severe adductors. The<br />
prepared tablets meet <strong>the</strong><br />
Pharacopoeial requirements and are<br />
more comfortable <strong>in</strong> use.<br />
Hypertension (High blood pressure)<br />
is a world‟s lead<strong>in</strong>g contributory<br />
case <strong>of</strong> death. It has estimated to<br />
have caused 7.6 million premature<br />
deaths and contributed to 92<br />
million disability adjusted life<br />
years worldwide <strong>in</strong> 2001. Ruchika<br />
Nanda et al (3 3 ) has found <strong>the</strong> use <strong>of</strong><br />
herbo-m<strong>in</strong>eral<br />
medic<strong>in</strong>e<br />
Rakatchaphar (conta<strong>in</strong>s Sarpganha,<br />
Shankhpushpi, Jatamansi, Jahar<br />
Mohra khatai Pishti, Moti Pishti<br />
and Ras s<strong>in</strong>door) <strong>in</strong> essential<br />
hypertension. It has <strong>of</strong>fered an<br />
efficacious and safe comb<strong>in</strong>ation <strong>of</strong><br />
natural product available for<br />
treatment <strong>of</strong> hypertension.<br />
Non-<strong>in</strong>sul<strong>in</strong> diabetes mellitus is<br />
one <strong>of</strong> <strong>the</strong> major diseases speared<br />
worldwide and over 85% <strong>of</strong><br />
diabetes mellitus is associated with<br />
high <strong>in</strong>cidence <strong>of</strong> mortalit y and<br />
morbidity. Maji D. and S<strong>in</strong>gh A. K.<br />
(3 4 )<br />
has reported a D-400<br />
herbom<strong>in</strong>eral preparation (conta<strong>in</strong>s<br />
Eugenia jambulana, Pterocarpus<br />
marsupium, Ficus glo merulata,<br />
Gymnema sylvestre, Momordica<br />
charantia, Ocimum sanctum and<br />
Shilajeet) is effective <strong>in</strong> treatment<br />
<strong>of</strong> Diabetes mellitus. They have<br />
studied <strong>the</strong> effect <strong>of</strong> D-400 on<br />
blood sugar level, serum<br />
cholesterol, triglycerides, LDL,<br />
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HDL, blood urea, serum creat<strong>in</strong><strong>in</strong>e<br />
levels and <strong>the</strong> effect <strong>of</strong> long-term<br />
diabetic complications. D-400 is<br />
shown to have beneficial effects as<br />
regards <strong>the</strong> long-term complication<br />
and can serve as an important<br />
adjuvant <strong>in</strong> <strong>the</strong> treatment <strong>of</strong><br />
diabetes.<br />
The ancient Indian (Asian)<br />
Ayurvedic medic<strong>in</strong>al system uses<br />
herbom<strong>in</strong>eral drugs to treat<br />
arthritis. Arv<strong>in</strong>d Chopra et al (3 5 )<br />
has tested RA-11 (ARTREX,<br />
MENDAR), a standardized<br />
multiplant Ayurvedic drug<br />
(Withania somnifera, Boswellia<br />
serrata, Z<strong>in</strong>giber <strong>of</strong>fic<strong>in</strong>ale, and<br />
Curcuma longa) <strong>in</strong> treatment <strong>of</strong><br />
arthritis. It has been reported that<br />
RA-11 is effective <strong>in</strong> <strong>the</strong><br />
symptomatic treatment <strong>of</strong><br />
osteoarthritis knees.<br />
Rasayana Tantra<br />
The word „Rasayana is composed <strong>of</strong><br />
two words „rasa‟ and „ayana. Rasa<br />
means dhatus responsible for<br />
sustenance <strong>of</strong> life. Ayana means<br />
specific measures uses for<br />
obta<strong>in</strong><strong>in</strong>g rasa and responsible for<br />
longevity. Rasayana is a well<br />
developed concept <strong>in</strong> Ayurveda.<br />
Rasayana means <strong>the</strong> augmentation<br />
<strong>of</strong> rasa, <strong>the</strong> vital fluid produced by<br />
<strong>the</strong> digestion <strong>of</strong> flood, which<br />
susta<strong>in</strong>s <strong>the</strong> body through <strong>the</strong><br />
streng<strong>the</strong>n<strong>in</strong>g <strong>of</strong> <strong>the</strong> dhatus<br />
(3 6 ) .<br />
The term „rasa‟ is derived from <strong>the</strong><br />
root „rasa‟ which means „to go‟.<br />
Therefore, <strong>the</strong> dhatus which always<br />
moves is called rasa. Rasayana is<br />
<strong>the</strong> medium through which <strong>the</strong> rasa<br />
Volume 3, Issue 3, May − June 2013<br />
is ma<strong>in</strong>ta<strong>in</strong>ed, replenished and<br />
augmented.<br />
In modern term, <strong>the</strong> study and<br />
practice <strong>of</strong> rasayana is referred as<br />
„rasavidya‟ (alchemy). Rasa<br />
ausadhis are known as metallic<br />
preparation which <strong>in</strong>cludes bhasma<br />
and s<strong>in</strong>doora. Metals like gold,<br />
silver, copper, lead, t<strong>in</strong> and iron,<br />
sand, lime and m<strong>in</strong>erals like red<br />
arsenic, germs, salts and red chalk<br />
are <strong>in</strong>dicated as drugs <strong>in</strong> Ayurveda.<br />
There are more than 200 plants<br />
mentioned <strong>in</strong> Rasashastra which<br />
uses m<strong>in</strong>eral and metals as<br />
medic<strong>in</strong>al plant or a desirable<br />
chemical property (3 6 ) .<br />
Bhasma<br />
Bhasma is an ash obta<strong>in</strong>ed by<br />
calc<strong>in</strong>ations <strong>of</strong> metals. It is a<br />
unique preparation <strong>of</strong> Ayurveda<br />
with extracts <strong>of</strong> herbs and metals <strong>in</strong><br />
comb<strong>in</strong>ation which functions best<br />
when converted from <strong>the</strong>ir orig<strong>in</strong>al<br />
metals to metal oxide forms (3 7 ) . It<br />
is prepared by calc<strong>in</strong>ations <strong>of</strong><br />
metals <strong>in</strong> a closed crucible <strong>in</strong> pits<br />
and with cow dung cakes (puta).<br />
Bhasmas are biologically produced<br />
nano-particles and are taken along<br />
with milk, butter, honey or ghee<br />
which makes <strong>the</strong>se elements easily<br />
assailable, elim<strong>in</strong>at<strong>in</strong>g <strong>the</strong>ir toxic<br />
effects and enhanc<strong>in</strong>g <strong>the</strong>ir<br />
biocompatibility (3 8 ) .<br />
Preparation <strong>of</strong> Bhasma (3 9 ) :<br />
It is prepared from purified<br />
m<strong>in</strong>erals, metals, mar<strong>in</strong>e and<br />
animal products. The process <strong>of</strong><br />
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purification is called Sodhana. It is<br />
aimed to remove harmful impurities<br />
present <strong>in</strong> <strong>the</strong> drug or sometimes<br />
modification <strong>of</strong> undesirable<br />
physical properties <strong>of</strong> <strong>the</strong> drugs. It<br />
helps <strong>in</strong> enhancement <strong>of</strong> <strong>the</strong><br />
<strong>the</strong>rapeutic action and <strong>the</strong>reby<br />
<strong>in</strong>creases <strong>the</strong> potency <strong>of</strong> drug.<br />
Sodhana is <strong>of</strong> two – Samanya<br />
sodhana applicable to a large<br />
number <strong>of</strong> metals or m<strong>in</strong>erals and<br />
Visesa sodhana applicable to<br />
certa<strong>in</strong> drugs and <strong>in</strong> certa<strong>in</strong><br />
preparation.<br />
After Sodhana, second stage is <strong>the</strong><br />
Marana which means metals and<br />
m<strong>in</strong>erals are made <strong>in</strong>to paste with<br />
various drugs and juices. It is<br />
essentially <strong>the</strong> burn<strong>in</strong>g process or<br />
calc<strong>in</strong>ation. It is subjected to fire<br />
treatment <strong>in</strong> a measured manner for<br />
reduc<strong>in</strong>g <strong>the</strong>m to ashes. The<br />
objective <strong>of</strong> do<strong>in</strong>g Marana Process<br />
is to reduce <strong>the</strong> size <strong>of</strong> <strong>the</strong> drug to<br />
its f<strong>in</strong>est particles so that it absorbs<br />
easily <strong>in</strong>to <strong>the</strong> system and produce<br />
<strong>the</strong>ir desired effects without<br />
produc<strong>in</strong>g harmful side effects.<br />
Types <strong>of</strong> Bhasmas (4 0 ) :<br />
Bhasmas are classified based on<br />
<strong>the</strong>ir color and appearance.<br />
Scientifically <strong>the</strong>y are classified<br />
based on <strong>the</strong>ir dom<strong>in</strong>ant metal and<br />
m<strong>in</strong>eral groups, such as Rajata<br />
bhasma (silver), Tamra bhasma<br />
(copper), Loha bhasma (iron),<br />
Pravala bhasma (Shells) etc.<br />
Bhasmas are generally yellowish,<br />
black, dark, white, gray, reddish<br />
black and red, depend<strong>in</strong>g upon <strong>the</strong><br />
Volume 3, Issue 3, May − June 2013<br />
predom<strong>in</strong>ant drug as well as <strong>the</strong><br />
o<strong>the</strong>r drugs used <strong>in</strong> <strong>the</strong> process <strong>of</strong><br />
marara. They are stored <strong>in</strong> air tight<br />
conta<strong>in</strong>er (glass or ear<strong>the</strong>n) and<br />
ma<strong>in</strong>ta<strong>in</strong> <strong>the</strong>ir potency <strong>in</strong>def<strong>in</strong>itely.<br />
Quality Control <strong>of</strong> Bhasma (4 1 ) :<br />
1. Nischandrika – No chandrika<br />
or metallic luster<br />
2. Rekhapurita – When taken<br />
between <strong>the</strong> <strong>in</strong>dex f<strong>in</strong>ger and<br />
thumb, it should be so f<strong>in</strong>e as<br />
to get easily <strong>in</strong>to <strong>the</strong> f<strong>in</strong>ger<br />
l<strong>in</strong>es.<br />
3. Varitara – Small quantity is<br />
spread on cold and still<br />
water, it should float on <strong>the</strong><br />
surface.<br />
4. Apurnabhava – It should not<br />
revert to <strong>the</strong> orig<strong>in</strong>al state.<br />
SINDOORA (37) :<br />
It is more potent preparation <strong>the</strong>n<br />
bhasma and prepared by <strong>the</strong><br />
elaborate process <strong>of</strong> sublimation.<br />
The preparation <strong>of</strong> s<strong>in</strong>doora process<br />
is called kupipakwa vidhi <strong>in</strong> which<br />
sublimed m<strong>in</strong>eral obta<strong>in</strong>ed on <strong>the</strong><br />
neck <strong>of</strong> <strong>the</strong> sublimation glass flask<br />
is called s<strong>in</strong>doora. Characteristics<br />
and preparation <strong>of</strong> s<strong>in</strong>doora is<br />
similar to Bhasma.<br />
CONCLUSION<br />
Cont<strong>in</strong>uous uses <strong>of</strong> conventional<br />
medic<strong>in</strong>es for various diseases may<br />
produces adverse actions and are an<br />
object <strong>of</strong> medical attention and thus<br />
<strong>the</strong> cause <strong>of</strong> concern. Hence<br />
alternative medic<strong>in</strong>es have become<br />
<strong>the</strong> need <strong>of</strong> <strong>the</strong> hour. <strong>Herbo</strong> -m<strong>in</strong>eral<br />
preparations are safe <strong>in</strong> <strong>the</strong>rapeutic<br />
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doses and absorbs easily <strong>in</strong> <strong>the</strong><br />
body. Bhasmas and S<strong>in</strong>doora, <strong>the</strong><br />
unique Ayurvedic preparation for<br />
cur<strong>in</strong>g diseases, can easily enter<br />
<strong>in</strong>to <strong>the</strong> blood stream and be come<br />
more biocompatible as compare to<br />
conventional medic<strong>in</strong>es. They have<br />
developed a new era <strong>in</strong> nano -<br />
medic<strong>in</strong>e system due to its nano<br />
particles size and holistic approach<br />
towards disease.<br />
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33. Nandha R, S<strong>in</strong>gh H, Moudgill P and<br />
Kular G. A pilot study to cl<strong>in</strong>ically<br />
evaluate <strong>the</strong> role <strong>of</strong> herbo-m<strong>in</strong>eral<br />
compound “Rakatchap Har” <strong>in</strong> <strong>the</strong><br />
management <strong>of</strong> hypertension. AYU.<br />
2011; 32(3): 329-323<br />
34. Maji D, S<strong>in</strong>gh AK. Cl<strong>in</strong>ical trial <strong>of</strong><br />
D-400 – A herbo-m<strong>in</strong>eral<br />
preparation <strong>in</strong> diabetes mellitus,<br />
Journal <strong>of</strong> Diabetes Association <strong>of</strong><br />
India. 1995; 35(1): 1-4<br />
35. Chopra A, Lav<strong>in</strong> P, Patwardhan B,<br />
Chitre D. A 32 Week Randomized,<br />
Placebo – Controlled Cl<strong>in</strong>ical<br />
Evaluation <strong>of</strong> RA-11, an Ayurvedic<br />
Drug, on osteoarthritis <strong>of</strong> <strong>the</strong> knees.<br />
Journal <strong>of</strong> Cl<strong>in</strong>ical Rheumatology.<br />
2004; 10(5): 236-245<br />
36. Dash and Kashyap. Basic pr<strong>in</strong>ciples<br />
<strong>of</strong> Ayurveda. Todarananda –<br />
Ayurveda saukhyam series. No. 2.<br />
Concept publish<strong>in</strong>g house. New<br />
Delhi. 61.<br />
37. Sheikh Raisuddi. Ayurvedic<br />
Bhasma, In: Scientific basis for<br />
Ayurvedic <strong>the</strong>rapies, Edited by<br />
Lakshmi Chandra Mishra. CRC<br />
Press LLC. 2004; 83-100.<br />
38. The Ayurvedic formulary <strong>of</strong> India.<br />
Part – II. The controller <strong>of</strong><br />
Publications. Civil l<strong>in</strong>es. Delhi.<br />
2000; 205-206.<br />
39. Kumar A, Nair AGC, Reddy AVR,<br />
Garg AN. Bhasmas – Unique<br />
Ayurvedic metallic-herbal<br />
preparations,<br />
chemical<br />
characterization. Biological trace<br />
element research. 2006; 109 (3):<br />
231-254.<br />
40. Paul S and Chugh A. Assess<strong>in</strong>g <strong>the</strong><br />
role <strong>of</strong> Ayurvedic Bhasma as Ethnonano-medic<strong>in</strong>e<br />
<strong>in</strong> <strong>the</strong> Metal Based<br />
Nanomedic<strong>in</strong>e Patent Regime.<br />
Journal <strong>of</strong> Intellectual Property<br />
Rights. 2011; 16: 509-511.<br />
41. Devanathan R. Concept <strong>of</strong><br />
Bhasmikarana. International Journal<br />
<strong>of</strong> Research <strong>in</strong> Ayurveda and<br />
Pharmacy. 2011; 2 (1): 18-23.<br />
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PHARMACEUTICAL INNOVATIONS ISSN 2249-1031<br />
Table – 1: Ayurvedic Herbal Medic<strong>in</strong>e Products Conta<strong>in</strong><strong>in</strong>g Lead, Mercury, and/or Arsenic<br />
Ayurvedic formulations Manufacturer Dosage form Metal Concentration (µg/g)<br />
Lead Mercury Arsenic<br />
Bal Chamcha Jalaram Powder 10 ND ND<br />
Bal Guti Zandu Tablet 5 ND ND<br />
Bala Sogathi Navjeevan Powder 43 28 ND<br />
Balguti Kesaria<br />
Kesari Ayurvedic Tablet 7 17600 37<br />
Pharmacy<br />
Maha Sudarshan Churna Dabur Powder 17 ND ND<br />
Maha Sudarshan Churna Zandu Tablet 40 ND ND<br />
Mahalakshmi Vilas Ras with Baidyanath Tablet 300 72100 2800<br />
Gold<br />
Navaratna Rasa<br />
Unja Ayurvedic Tablet 600 10400 60<br />
Pharmacy<br />
Shilajit Syncom Capsule 8 ND ND<br />
Abbreviations: ND = not detected (Heavy metal assay report<strong>in</strong>g levels lead > 5 µg/g, mercury ><br />
20 µg/g, and arsenic > 10 µg/g.<br />
Table- 2: The most important disasters with heavy metals<br />
Year Disasters Remarks<br />
1932 M<strong>in</strong>amata Sewage conta<strong>in</strong><strong>in</strong>g mercury is released by Chisso's chemicals works <strong>in</strong>to<br />
M<strong>in</strong>imata Bay <strong>in</strong> Japan. The mercury accumulates <strong>in</strong> sea creatures, lead<strong>in</strong>g<br />
eventually to mercury poison<strong>in</strong>g <strong>in</strong> <strong>the</strong> population.<br />
1952 M<strong>in</strong>amata<br />
Syndrome<br />
In 1952, <strong>the</strong> first <strong>in</strong>cidents <strong>of</strong> mercury poison<strong>in</strong>g appear <strong>in</strong> <strong>the</strong> population <strong>of</strong><br />
M<strong>in</strong>imata Bay <strong>in</strong> Japan, caused by consumption <strong>of</strong> fish polluted with<br />
mercury, br<strong>in</strong>g<strong>in</strong>g over 500 fatalities. S<strong>in</strong>ce <strong>the</strong>n, Japan has had <strong>the</strong> strictest<br />
environmental laws <strong>in</strong> <strong>the</strong> <strong>in</strong>dustrialised world.<br />
1986 Sandoz Water used to ext<strong>in</strong>guish a major fire carries c. 30 t fungicide conta<strong>in</strong><strong>in</strong>g<br />
mercury <strong>in</strong>to <strong>the</strong> Upper Rh<strong>in</strong>e. Fish are killed over a stretch <strong>of</strong> 100 km. The<br />
shock drives many FEA projects forwards. See also "Pollution <strong>of</strong> <strong>the</strong> Rh<strong>in</strong>e at<br />
Basel / Sandoz".<br />
1998 Spanish<br />
nature<br />
reserve<br />
contam<strong>in</strong>at<br />
ed after<br />
environme<br />
ntal<br />
disaster<br />
Toxic chemicals <strong>in</strong> water from a burst dam belong<strong>in</strong>g to a m<strong>in</strong>e contam<strong>in</strong>ate<br />
<strong>the</strong> Coto de Donana nature reserve <strong>in</strong> sou<strong>the</strong>rn Spa<strong>in</strong>. C. 5 million m_ <strong>of</strong> mud<br />
conta<strong>in</strong><strong>in</strong>g sulphur, lead, copper, z<strong>in</strong>c and cadmium flow down <strong>the</strong> Rio<br />
Guadimar. Experts estimate that Europe's largest bird sanctuary, as well as<br />
Spa<strong>in</strong>'s agriculture and fisheries, will suffer permanent damage from <strong>the</strong><br />
pollution.<br />
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PHARMACEUTICAL INNOVATIONS ISSN 2249-1031<br />
Table-3 Global Emissions <strong>of</strong> Trace Metals <strong>in</strong>to <strong>the</strong> Atmosphere, Water and Soil (<strong>in</strong> 1 000 metric<br />
tonnesyr -1 )<br />
Element Air Water Soil<br />
Arsenic 18.8 41 82<br />
Cadmium 7.6 9.4 22<br />
Chromium 30 142 896<br />
Copper 35 112 954<br />
Mercury 3.6 4.6 8.3<br />
Indium 0.02 - -<br />
Manganese 38 262 1670<br />
Molybdenum 3.3 11 88<br />
Nickel 56 113 325<br />
Lead 332 138 796<br />
Antimony 3.5 18 26<br />
Selenium 3.8 41 41<br />
T<strong>in</strong> 6.4 - -<br />
Thallium 5.1 - -<br />
Vanadium 86 12 132<br />
Z<strong>in</strong>k 132 226 1372<br />
Table-4: Typical Presentation <strong>of</strong> <strong>the</strong> Most Commonly Encountered Metals and Their<br />
Treatment<br />
Metal Acute Chronic Toxic Concentration Treatment<br />
Arsenic<br />
Lead<br />
Mercury<br />
Nickel<br />
Nausea, vomit<strong>in</strong>g,<br />
"rice-water" diarrhea,<br />
MODS, LoQTS,<br />
pa<strong>in</strong>ful neuropathy<br />
Nausea, vomit<strong>in</strong>g,<br />
encephalopathy<br />
(headache, seizures,<br />
ataxia, obtundation)<br />
Elemental (<strong>in</strong>haled):<br />
fever, vomit<strong>in</strong>g,<br />
diarrhea, ALI;<br />
Inorganic salts , caustic<br />
gastroenteritis<br />
Dermatitis; nickel<br />
carbonyl: myocarditis,<br />
ALI, encephalopathy<br />
Diabetes,<br />
hypopigmentation/<br />
hyperkeratosis, cancer:<br />
lung, bladder, sk<strong>in</strong>,<br />
Encephalopathy,<br />
anemia, abdom<strong>in</strong>al pa<strong>in</strong>,<br />
nephropathy, foot-drop/<br />
wrist-drop<br />
Nausea, metallic taste,<br />
g<strong>in</strong>givo-stomatitis,<br />
tremor, neuras<strong>the</strong>nia,<br />
nephrotic syndrome;<br />
hypersensitivity<br />
Occupational (<strong>in</strong>haled):<br />
pulmonary fibrosis,<br />
reduced sperm count,<br />
nasopharyngeal tumors<br />
24-h ur<strong>in</strong>e:<br />
≥50 µg/L ur<strong>in</strong>e, or<br />
100 µg/g creat<strong>in</strong><strong>in</strong>e<br />
Pediatric: symptoms<br />
or [Pb] ≥45 µ/dL<br />
Adult: symptoms or<br />
[Pb] ≥70 µ/dL<br />
Background exposure<br />
"normal" limits:<br />
10 µg/L (whole<br />
blood); 20 µg/L (24-h<br />
ur<strong>in</strong>e)<br />
Excessive exposure:<br />
≥8 µg/L (blood)<br />
Severe poison<strong>in</strong>g:<br />
≥500 µg/L (8-h ur<strong>in</strong>e)<br />
BAL (acute,<br />
symptomatic)<br />
Succimer<br />
DMPS (Europe)<br />
BAL<br />
CaNa 2 EDTA<br />
Succimer<br />
BAL<br />
Succimer<br />
DMPS (Europe)<br />
*No accepted chelation regimen; contact a medical toxicologist regard<strong>in</strong>g treatment plan.<br />
MODS - multi-organ dysfunction syndrome; LoQTS - long QT syndrome; ALI - acute lung <strong>in</strong>jury; DMPS<br />
- 2,3-dimercapto-1-propane-sulfonic acid; CaNa 2 EDTA - edetate calcium disodium.<br />
*<br />
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Table – 5: List <strong>of</strong> <strong>Herbo</strong>-m<strong>in</strong>eral formulations used <strong>in</strong> various common disorders.<br />
S. N. <strong>Herbo</strong>-m<strong>in</strong>eral formulations Common disease<br />
1. Godanti Bhasma Cold, Cough, Fever<br />
2. Shankh Bhasma Acidity, Ulcer<br />
3. Yashad Bhasma Myopia, Diabetes<br />
4. Trushanadi loha Anemia<br />
5. Loha bhasma Anemia<br />
6. Navayasa loha Anemia<br />
7. Arogyavardh<strong>in</strong>i vatti Hepatitis, Diabetes, Sk<strong>in</strong> diseases, obesity<br />
8. Tribhuvan kirti Rasa Fever<br />
9. Shvass kuthar Rasa Asthma<br />
10. Swarna makherdhwaj Rasayan Diabetes, fertility<br />
11. Sutshekhar Rasa Acidity<br />
12. Hirdyarnava Rasa Heart diseases<br />
13. Laxmivias Rasa Respiratory track disorders, common cold<br />
14. Chandra prabha vatti Diabetes, Ur<strong>in</strong>ary track disorders<br />
15. Saptamrata lauha Eye disorders<br />
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