HG51
Feature
Medicinal Plant Remedies and Nutraceuticals from Ukraine and Georgia
by Tanya Kuritz, Ph.D.1
with Lidia A. Sirenko,
Ph.D.,2 Tatyana V. Parshikova, Ph.D.,3 Levan
Topchishvili, Ph.D.,4 and Arthur Sass, Ph.D.5
1. Oak
Ridge National Laboratory, Oak Ridge, Tennessee.
2. Institute
of Hydrobiology, Academy of Sciences of Ukraine, Kiev, Ukraine.
3. Shevchenko
Kiev National University, Kiev, Ukraine.
4. Institute
of Physics, Academy of Sciences of Georgia, Tbilisi, Georgia.
5. Sass
and Sass, Inc., Kingston, Tennessee.
For centuries, people living in Eastern Europe and the
Caucasus have relied upon plants as sources of medication as well as food.
During the past 70 years, fast-paced regional industrialization has paid little
attention to the environment, human health, or quality of life. Traditional
methods of health maintenance -- including use of botanicals as foods, dietary
supplements and medicinals -- have been both a necessity and a commodity. Today,
as Western markets are ready to embrace new products, the ability to reach and
to use the knowledge and experience accumulated in the Former Soviet Union
(FSU) is critical and valuable. Nonetheless, business efforts with FSU
countries are sporadic and dominated by non-professionals, whose reports of
loss and failure discourage other ventures. This paper attempts to provide a
brief account of the resources, business environment, and opportunities related
to botanicals available in Ukraine and Georgia.
Botanicals as regulated substances
As with every other product, botanicals were regulated by
the Soviet government. Until 1992, approval of botanicals was a duty of the
Pharmacological Committee of the Soviet Ministry of Health. As the free market
did not exist in the Soviet Union, those approvals provided consumer protection
only and were not intended for market protection. However, approvals were
necessary before another Ministry of Health agency, the Pharmacy Directorate,
would allow these products to be sold through its system of pharmacies.
Approval of new botanicals (regulated as "natural medicinal substances") were
granted upon successful completion of these three criteria:
1. pre-clinical
studies, including toxicological studies on three species of mammals;
2. clinical
studies conducted at specialized hospitals selected by the Pharmacological Committee;
3. certification
and approval of collection, manufacturing procedures, storage procedures, etc.
Pre-clinical studies followed standard procedures set by the
Ministry of Health. Approval for the commencement of clinical studies was
granted when pre-clinical studies were successful. Requirements for botanicals
were registered in the Pharmacopoeia of the USSR. Starting in the 1960s, protocols for standardization, and quality
control and assurance were developed for more than 200 plants used as raw materials.
Botanicals developed and used in the former Soviet republics
were also registered in the respective republics by agencies that mirrored the
federal agencies. After the disintegration of the Soviet Union, registration
and approval of new botanicals has been conducted by national governmental
institutions, which pattern their structure and methods of operation on the
former USSR. USSR pharmacopeia standards and approvals continue to be honored
in Ukraine and Georgia, as well as most other former Soviet republics.
Ukraine -- Preservation of plant diversity and botanicals as
commodities
Ukraine is the second largest country among the satellite
states that gained independence after the breakdown of the Soviet Union. Before
that, this country was the most industrialized among the satellite states.
Since gaining its independence in December 1991, Ukraine has endured economic
problems. For example, output in 1992-1998 fell to less than half the 1991
level.1,2 The
situation still has not improved in the past few years; gross domestic product
(GDP) decreased to -1.7% in 1998, and fell further, to an estimated -3.2% GDP
in 1999.1-3, Gross
National Product per capita was $854 in 1998 and estimated as $830 for 1999.1,2
Ukraine's biodiversity is very rich. Several botanical
surveys have described 4,497 species of vascular plants.4,5 These plant species belong to 997 genera
in 189 families.4,5
About 65% of all vascular plant species are used in agriculture, food
supplements, medicines, horticulture, forage, and construction materials.
Approximately 800 plant species are used in ethnomedicine; about 200 of these
have been registered as "natural medicinal substances" and approved for human
use through the national regulatory system.5 About 150 vascular
plant species are sources of vitamin supplements.5 Ukraine also
accounts for 4,161 species of aquatic plants, of which 3,708 are freshwater
organisms.6
Plant biodiversity is preserved through a system of national
parks and reserves.7 Of the three major national parks called
Biosphere Reservations, the oldest, Askania-Nova, was founded in 1898. Some
five million acres in Ukraine are covered by wildlife protection, and
preservation areas comprise more than 3% of the country's territory.7 After the Chernobyl
nuclear power plant accident in 1986, more emphasis has been given to
environmental and wildlife preservation. In 1997 the Ukrainian Cabinet of
Ministers sponsored the National Interagency Scientific and Technology Program
on Ecological Diagnostics, Expertise, and Monitoring. This program was
considered a continuation of the Program on the Prospective Development of
Wildlife Preservation Activities in Ukraine, sponsored and adopted by the Rada
(Ukrainian Parliament) for 1995-2000. This program added another 465,000 acres
of land and established four new wildlife reserves. To increase public
awareness, the government established commemorative days, including Earth Day,
Environment Protection Day, Day of Water, and Biodiversity Preservation Day.
Use of plants is extremely popular in Ukraine across social
and ethnic divisions. Many ethnobotanical applications have been preserved in
the western, less industrialized, region of Ukraine, where witchcraft and
shamanism are a part of daily life. A plummeting economy, deficits and unavailability
of health care and hygienic supplies, and a decrease in standards of living
have led to increased use of botanicals. Without a market economy, however,
this increased demand did not stimulate a growth in supply through official
commercial channels. Uniform poverty and theft of government resources has
halted botanical manufacture at some Ukrainian facilities. Pharmacies continue
to sell regulated botanical products with approved claims; however "official"
herbs and extracts retail between $2.50 to $60 for a kilogram of a final
product, which is beyond the reach of the average $27 monthly per capita
income.1 Instead,
many consumers purchase numerous unregulated products through street vendors
and farmers' markets.
Regulated botanicals (formulated as dry powders, blends,
extracts, or ointments) are sold as over-the-counter (OTC) or prescription
drugs. Most physicians know botanicals and include them in treatment plans. In
addition to general practice physicians, who choose between conventional pharmaceuticals
and regulated botanicals, homeopathic physicians offer regulated botanicals
formulated as homeopathic preparations.
Approved botanical medications packaging includes the
following information:
The front panel features the common name of the plant in
Russian or Ukrainian, the Latin name, pharmacopeial name, and, often, a drawing
of the plant itself. Side panels carry information on indications and
contraindications, side effects, dosage, standard treatment plans, methods of
application, storage requirements and the regulatory file number. Compliance
with an official Pharmacopoeia Article is designated by two Cyrillic letters
followed by a number, which indicate that the product's quality meets the
standards set by the Pharmacopoeial Article and gives a reference to that
article. All listed claims were tested and approved by the regulatory body of
the USSR and/or Ukraine. Since the Chernobyl accident, the package also carries
state certification of radiological testing. In Ukraine, radiation control is
mandatory for all products intended for internal use. The radiological testing
is carried out by the Department of Radiological Control, Ministry of Ecology
of Ukraine before its sale to the public is allowed. Approval for consumer
sales is acknowledged by a seal manifested on the top or face panels of each
package of herbal material distributed through government-approved channels
(stores, pharmacies, markets, etc.).
Georgia -- Country of the Golden Fleece
Known from Greek mythology as the Country of the Golden
Fleece, Georgia is a small, mountainous country in the Caucasian Region,
slightly larger than South Carolina. After unrest and decline in the early
1990s, Georgia has progressed toward political and economic stability over the
past few years. In 1996 and 1997, Georgia had one of the fastest growing
economies among former Soviet countries, with GDP growth over 10% to 11%
percent for 1996-1997.1,2
With a variety of climates -- subtropical to alpine -- Georgia
is rich in native plant diversity. However, these species have not been
thoroughly surveyed or documented. During Russian domination in the 19th
century, some Chinese medicinal plants and tea (Camellia sinensis (L.) Kuntz, Theaceae) were introduced as crop
cultures. By the 1990s Georgia had one of the most diverse agricultural bases
in the former Soviet Union. However, crop yields in Georgia are far below their
production potential. After the USSR's disintegration, Georgia lost export
markets, which resulted in the decrease in botanical production. Many
production facilities are working at a fraction of capacity or are idle.
However, availability of resources and potential for production upscaling are
promising.
Preservation of wild plant diversity is ensured through the
system of reserves, of which most prominent is Kazbegi Nature Reserve,
established in 1976 and covering an area of more than 20,000 acres. This
reserve accounts for 1,347 plant species, many of which are native.
In Georgia, reliance on botanicals for food and medicine is
deeply rooted in the people. Ethnomedicine is a part of folklore and is also a
subject of scientific research. Current regulations categorize herbal
medicines, health foods, supplements and other botanicals as "semi-medicinal
preparations."8
Homeopathic plant extracts and other products are regulated as "homeopathic
preparations." Both categories are regulated by the Pharmacological Committee
of the Drug and Pharmacy Department of the Georgian Ministry of Health8 -- a system similar to
patterns established during the days of the USSR -- and are registered in
Georgian State Drug Register. As in Ukraine, regulated substances are
distributed through pharmacies.
Technology transfer and trade with Ukraine and Georgia
The research and personal experience reported here lead to several
conclusions that may be helpful for businesses intending to work with Ukraine
and Georgia.
Several major problems may obstruct successful trade and
cooperation between the U.S. and Ukraine and Georgia. Cultural differences --
and U.S. businesses' difficulties in recognizing them -- have been notorious
stumbling blocks for a long time, and continue to affect businesses. This
problem is exacerbated by the poor system of telecommunications in Ukraine and
Georgia. For instance, Ukraine has about 18 telephones per 100 persons, and
Georgia has 20 telephones per 100 persons in urban areas and 4 phones per 100
persons in rural areas.1,3
Both countries also lack necessary regulation and
infrastructure to support business; however, this situation has been improving
faster in Georgia than in Ukraine. Both countries lack business expertise and
adequate law enforcement. This means that an American company always depends on
personal relationships with its Ukrainian or Georgian partner. Although this
situation seems risky and unacceptable for some, others enjoy enduring success
and protection through good personal and long-term relationships. Ukraine also
has excessive and ambiguous taxation, which may assess up to 17 different taxes
on a product.1
In the authors' opinion, however, if an appropriate working
relationship can be established, there are important benefits that make efforts
in Ukraine and Georgia worthwhile; both countries possess unique expertise and
can offer a large number of quality botanical products, the safety and efficacy
of which have been tested and documented through scientific research. Due to
the rigid regulation that started in the USSR and continues today in the
regulatory systems of Ukraine and Georgia, botanical products currently
marketed through government-controlled channels in those countries have passed
rigorous testing and carry substantiated and approved claims. Both countries'
national governments support bioprospecting and development of new
nutraceutical products and have sources of raw materials and workers who are
well-trained and yet offer relatively inexpensive expertise and skills. The
systems in both countries lack organization and will require long-term
commitment by the western partner to establish a productive environment. The
authors believe that utilization of these resources can strengthen the
botanical market in the U.S. and provide consumers with a wider array of high
quality botanical ingredients to incorporate into personal dietary and health
regimes.
Correspondence to: Tanya Kuritz, Oak Ridge National
Laboratory, MS-6194, Oak Ridge, TN 37831-6194. Phone: 865/241-6013; Fax:
865/574-1275; email: <kuritzt@ornl.gov>.
Research in Ukraine was supported in part by Civilian
Research and Development Foundation Grant U1-320. Research in Georgia was
supported in part by U.S, DOE Office of Arms Control and Nonproliferation
(NN-42). The authors are grateful to Helen M. Bird for the support of efforts
in Georgia. Partial funds and research in business and economics were
contributed by Sass & Sass, Inc. and from the lead author's company, B2B
Botanicals Inc. Oak Ridge National Laboratory is managed by UT-Battelle, L.L.C.
for the U.S. Department of Energy under contract DE-AC05-00OR22725.
References:
1. U.S.
Department of Commerce. Business Information Service for the Newly
Independent States (BISNIS), Country Report. Washington, DC: U.S. Department of Commerce; 1999.
2. U.S.
Central Intelligence Agency. CIA Sourcebook. Washington, DC: U.S. Central Intelligence
Agency; 1999.
3. WIIW
Handbook of Statistics: Countries in Transition 1999. Vienna, Austria: The Vienna Institute for
International Economic Studies; 1999.
4. Prokoudin
YN, editor. Field Guide to Higher Plants of Ukraine (in Ukrainian). Naukova Dumka: Kiev, 1987.
5. Mosyakin
SL, Fedoronchuk MM. Vascular plants of Ukraina (in Ukrainian). Kiev: Naukova Dumka;1999.
6. Tsarenko
PM, Palamar'-Mordvintseva GM, Vasser SP. Diversity of Ukrainian algae
(preliminary data). Algologiya
(in Russian) 1998;8:227-41.
7. Stetsenko
M. Nature reserve business is a priority of national nature preservation
policy. Motherland Nature (in
Ukrainian) 1998, Issues 1-3:10-13.
8. Types
of Medicinal Products. U.S.
Embassy in Georgia, December, 1998.
9. Takhtadzhian
AL, editor. Life of Plants (in
Russian). Vol. 5, parts 1 and 2. Moscow: Prosveshenije; 1981.
10. Mamchour
FI. Plants Heal (in
Ukrainian). Kiev: Znanija; 1971.
11. Zinchenko
TV, Stakhiv IV, Miakushka TY, Kaloshina NA, Nikonov GK Medicinal Plants in
Gastroenterology (BV Zavirukha,
editor, in Russian). Kiev: Naukova Dumka; 1990.
12. Pavlenko
LO. Healing Products of Earth.
2nd ed. (in Ukrainian). Kiev: Naukova Dumka; 1988.
13. Rabinovich
AM. Medicinal Plants in the Backyard (in Russian). Moscow: Rosagropromizdat; 1989.
14. Nosal'
MA, Nosal' IM. Medicinal Plants and Methods of Their Ethnic Applications (in Ukrainian). Kiev: State Medical Publishing
House; 1958.
Doudchenko LG, Krivenko
VV. Edible Plants-Healers. 2nd
ed. (in Russian). Naukova Dumka: Kiev, 1988.
Sidebar
Herbs of Ukraine
The following are 20 examples of approximately 200
botanicals commonly used in Ukraine and less known in America. Their official
and/or popular uses are mentioned briefly. The selection is limited and biased,
as the described herbs are considered by the authors to be of major interest.
Alnus
glutinosa (L.) Gaerth [Betulaceae], common alder fruit, is used
to soothe chronic and acute colitis and enterocolitis due to its high
concentration of tannins.9,10
Artemisia
absinthium L.
[Asteraceae], wormwood, is made into a tea from the whole dried plant to induce
appetite and to stimulate gastrointestinal function.
Bidens
cernua L. [Asteraceae],
tickseed or bur marigold, is formulated as dry powder from the whole plant.
Aqueous extract is used as an over-the-counter treatment in pediatric practice
for baths and for prevention of skin rashes.10,11 May be prescribed
to adults as diuretic and sudorific for internal use.
Crataegus
sanguinea Pall.
[Rosaceae], hawthorn, fruit is used as general tonic in patients with a variety
of cardiac and circulatory problems, including congestive heart failure and
cardiac angina.12 In addition to fruit extracts, several other
formulations are used as herbal medicinals for cardiac stimulation and control
of blood cholesterol levels.12
Delphinium
spp. [Ranunculaceae], or larkspur,
formulations have a variety of prescription-only applications for treatment of
neurologic diseases, muscle relaxation and treatment of motor disorders.
Erysimum
diffusum Ehrh. [Brassicaceae or Cruciferae], wallflower, is used
only in prescription formulations for a variety of cardiac disorders and
deficiencies, its primary active ingredient being the cardioactive compound
erysimilacton.9
Eucalyptus
viminalis Labill.
[Myrtaceae], teas from the leaves of the manna gum tree are used as antiseptics
for gargling, wound treatment and treatment of gynecological inflammatory
processes.
Hippophae
rhamnoides L.
[Elaeagnaceae], sea buckthorn, is probably a rising star in the American
market. Its tasty, zesty fruit is used for juices and preserves, and its
extracts are widely used for treatment of ulcers, gastrointestinal disorders,
burns and gynecological inflammations.9,13 Various sea buckthorn
products are used as vitamin supplements.9,13 The berry
kernel oil is considered the most valuable formulation and was regulated
through the Pharmacopoeia of the USSR and its national system of standardization, although juices, teas,
infusions and preserves are very popular too. The plant is performing
exceptionally well in Russian, Ukrainian and other Former Soviet Union, Eastern
European and Scandinavian markets.
Leonurus
cardiaca L. [Lamiaceae], motherwort, is used for circulatory
disorders,9 including stenocardia and hypertension.13 The
plant serves as a source of a variety of alkaloids (up to 0.4% dry weight) and
steroid and flavonoid glycosides, such as quercitin, rutin, and quinqueloside.13
Prunus
padus L. [Rosaceae], bird cherry tea is a common and well-known
remedy, prescribed for lower gastrointestinal problems.
Photinia
melanocarpa (syn. Aronia melanocarpa (Michx.) Elliot) (Michx.) Robertson & Phipps
[Rosaceae], or black chokeberry,
is probably one of the next market successes. The plant was introduced from
America and gained popularity due to its medicinal properties and hardiness.
The ripe fruits are widely used in many Eastern European countries as immune
system booster and to control blood pressure in hypertension sufferers.13
It is also used as a vitamin supplement for venous conditions.13
Plantago
major L. [Plantaginaceae], plantain leaves serve as a basis of
several formulations used for burn and wound treatment and for gynecological
inflammatory processes.13,14
Potentilla erecta (L.) Raeusch. [Rosaceae], cinquefoil, or five-finger
grass, is used to improve gastrointestinal function, for digestive problems,
and as antiinflammatory for gingivitis and gum problems. Herbal medicines use
plant roots, which are rich in tannins (up to 35%), contain tormentillin,
zineol and other glycosides and ethers.13
Quercus
robur L. [Fagaceae],
English oak bark is used to prevent and control gum disease.13,14
Rosa
canina L. [Rosaceae], dog rose extracts are used to improve liver
and gastrointestinal function. The dog rose syrup and teas are prescribed and
used for symptomatic relief of liver function deficiencies and for stimulation
of liver and gall bladder functions.15
Sambucus
nigra L. [Caprifoliaceae], European, or black elder is used for
circulation improvement and for asthma relief. It promotes perspiration and
relieves common cold symptoms.
Thalictrum
foetidum L. [Ranunculaceae], stinking meadow rue is used for
blood pressure control in hypertensive patients.
Tilia
cordata Mill. [Tiliaceae], linden tree flowers are used as a
sudorific (promotes perspiration) and to reduce fever. They are used to relieve
symptoms of the common cold.
Tussilago
farfara L. [Asteraceae], coltsfoot is used as an expectorant in
patients with tracheitis, laryngitis, bronchitis, pneumonia or asthma.
Vinca
minor L. [Apocynaceae],
periwinkle is commonly used for blood pressure control in hypertensive
patients.
Development of new botanical products continues in Ukraine's
numerous research institutions and centers. Among the successes of recent
years, registration and approval for clinical use of Algofinª in
1998 -- an ointment containing extract of local algal species (Nostoc and Chlorella spp.) -- deserve mention. The ointment has been approved for clinical
use in wound and burn clinics, and for dermatological
disorders.
Herbs of Georgia
Some examples of Georgian botanicals include:
Brassica
rapa var. rapifera L.
[Cruciferae or Brassicaceae], turnip, and its fruit juices are general dietary
supplements that have been in the market for more than 20 years, and
distributed in Georgia, Ukraine and Russia.
A healthy breakfast fruit butter of Cornelian cherries (Cornus spp. L., Cornaceae) has been in the market for 15 years and
is recognized as a tasty, vitamin-rich, and filling supplement.
A sauce, known as "Ushkuni," made of various local wild plum
species, is used as both meat seasoning and for blood pressure control in
hypertensive patients. The main ingredient is barberry fruit (Berberis spp., mainly B. vulgaris L., Berberidaceae).
"Alcohol balm" and "Concentrate" are used as tonic
supplements and for general health improvement. The products have been approved
and marketed in Georgia, Russia, and Ukraine. The products are composed of
extracts of endemic and common herbs:
Acca
sellowiana (O.Berg) Burret,
Myrtaceae;
Aerva
lanata (L.) ex Schult.,
Juss., Amaranthaceae;
Aloe
arborescens Mill,
Liliaceae;
Camellia
sinensis (L.) Kuntz, Theaceae;
Citrus
aurantium L. Rutaceae;
Citrus
limon (L.) Osbeck,
Rutaceae;
Diospyros
lotus L., Ebenaceae;
Eleutherococcus
senticosus (Rupr. &
Maxim) Maxim, Araliaceae;
Ficus
carica L., Moraceae;
Juglans
regia L., Juglandaceae;
Lagochilus
inebrians A. Bunge,
Labiatae;
Olea
europaea L., Oleaceae;
Orthosiphon
stamineus Benth.,
Labiaceae;
Panax
ginseng C.A.Mey, Araliaceae;
Quercus
pontica K.Koch, Fagaceae;
Rhododendron
caucasicum Pall., Ericaceae;
Rubus
caesius L., Rosaceae;
Sedum
rosea (L.) Scop., Crassulaceae;
Vitis
vinifera 'Saperavi' L.
(endemic variety), Vitaceae; and propolis from bee hives.