Herbal Med 2008-09-05 (Narrow, No Anima)

HERBAL MEDICINE
University of Santo Tomas

Faculty of Medicine and Surgery
Department of Pharmacology
Seminar on
HERBAL
MEDICINE
Balan, Lim, J., Lim, V., Macasaet, Madulara, Maulion, Medina, Nallas, Ong, Ongoco, Palma
HERBAL MEDICINE
Introduction History The 10 DOH Herbal Medicines Potential Harm
Drug and Herb-herb Interactions
efinition of Terms
Traditional and Alternative

Health Care
The sum total of knowledge, skills
and practices on health care, other
than those embodied in
biomedicine, used in the
prevention, diagnosis and
elimination of physical or mental
disorder
Lim, Maria Joane Faye C. Class No. 22

HERBAL MEDICINE
efinition of Terms
Traditional
Medicine
The sum total of knowledge, skills
and practice on health care, not
necessarily explicable in the context
of modern, scientific philosophical
framework, but recognized by the
people to help maintain and improve
their health.

HERBAL MEDICINE
efinition of Terms
BIOMEDI
CINE
A discipline of medical care
advocating therapy with remedies
that produce effects differing from
those of the diseases treated.

HERBAL MEDICINE
efinition of Terms
BIOMEDI
CINE
Practiced by holders of M.D.
(medical doctor)
or D.O. (doctor of osteopathy)
degrees and by their allied health
professionals, such as physical
therapists, psychologists, and
registered nurses

HERBAL MEDICINE
efinition of Terms
BIOMEDI
CINE
Also called allopathy, western
medicine, regular medicine,
conventional medicine,
mainstream medicine, orthodox
medicine, or cosmopolitan
medicine.

HERBAL MEDICINE
efinition of Terms
Alternative Health Care

Modalities
Other forms of non-allopathic,
occasionally non-indigenous or
imported healing methods, though not
necessarily practiced for centuries nor
handed down from one generation to
another.
Some of the modalities are reflexology,

acupuncture, chiropractic care,
acupressure, massage, applied
HERBAL MEDICINE
efinition of Terms
HERBAL
MEDICINE
Finished, labeled
Medicines containing
medicinal
plant material(s)
products
that contain
combined with
as chemically-defined
active ingredient/s
aerial substances,
active or underground
including
part/s of
plant or other materials
chemically-defined, isolatedor
combinationofthereof,
constituents plants, whether in the
crude
are NOTstateconsidered
or as plant preparations.
to be
herbal medicines.
However, it may contain excepients in
addition to the active ingredient(s).
HERBAL MEDICINE
efinition of Terms
Natural
Product
Foods that grow spontaneously in nature
whether or not they are tended by man.
Foods that have been prepared from

grains, vegetables, fruits, nuts, meats, fish,
eggs, honey, raw milk, and the like, without
the use or addition of additives,
preservatives, artificial colors and flavors,
or manufactured chemicals of any sort
after harvest or slaughter
HERBAL MEDICINE
efinition of Terms
Manufac
ture
Any and all operations involved in the
production:
including preparation, propagation, processing,

formulating, filling, packing, repacking,
altering, ornamenting, finishing, or otherwise
changing the container, wrapper, or labeling of
a consumer product in the furtherance of the
distribution of the same from the original place
of manufacture to the person who makes the
final delivery or sale to the ultimate consumer.
HERBAL MEDICINE
efinition of Terms
Traditional
Healers
Relatively old, “highly” respected people with
a profound knowledge of traditional remedies
They have strong ethical principles that they

extend to all life.
They believe it is their duty to foster life in all

its forms and to alleviate suffering.
They also believe that Nature's laws must be

obeyed in order to avoid decline and ultimate
disaster.
HERBAL MEDICINE
efinition of Terms
Intellectual
Property Rights
Legal basis by which the indigenous
communities exercise their rights 'to
have access to protect, control over
their cultural knowledge and product,
including but not limited to, traditional
medicines, and includes the right to
receive compensation for it.

HERBAL MEDICINE
ntegrated Research Program on Medicinal Plants (NIR

is a multi disciplinary, multi-agency effort iniated
by National Science and Development Authority
(NSDA), now the Department of Science and
Technology (DOST) in 1974 which aims to:
provide the scientific ground work for the
further development of Herbal medicine in the
Philippines
systematize the study of medicinal plants in

the Philippines with an end goal of providing
safe, effective, and affordable pharmaceutical
products derived from commonly available
plants
Ongoco, Renncee A. Class
No. 113
HERBAL MEDICINE

Two IMMEDIATE DRUG NEEDS identified by
NIRPROMP
1. Need to distribute medicines within
the reach of most Filipinos (safe,
effective but affordable to Filipinos)
2. Need to discover new or better drugs

for common diseases in the Philippines.

No. 113
HERBAL MEDICINE

Done researches in developing herbal plants in
dosage forms with consistent potency. 2
preliminary steps:
They plan and develop the fastest way
to get the raw materials needed ( in
terms of cultivation, growing,
maintenance and harvest of plants)
Harvested leaves are then brought to
U.P. College of Pharmacy to be
processed, but first tested
HEAVY – METALScounts
MUTAGENIC
PESTICIDE
AFLATOXIN
Microbial RESIDUES
and not
Harvested plant shouldn’t contain:
(shouldn’t exceed WHO
TERATOGENIC
exceeding approved
100,000 leve
COMPOUNDS
colony forming units
No. 113
HERBAL MEDICINE

To date, NIRPROMP has transferred the
technology to pharmaceutical
manufacturers for the production of
7 herbs in commercial form:
SAMBON TSAANG
LAGUN
G GUBAT
DI
HIERBA A ACAPULC
BUENA TI O
AMPALAY
S
A

No. 113
HERBAL MEDICINE

Latest Achievements of
NIRPROMP
Recent reclassification of ampalaya back to
its previous status as a scientifically
validated herbal medicinal plant by using a
phase 3 clinical trials.
Compared the efficacy and safety of
Momordica Charantia, L (ampalaya Makiling
variety) leaf tablet and glibenclamide
among patients with Type 2 DM
Pascual Laboratories Inc. has secured the
license to manufacture, distribute and market a
new Ampalaya (bitter gourd) tablet as an anti-
diabetic medicine developed by NIRPROMP.
No. 113
HERBAL MEDICINE

NIRPROMP
Today:
Screens more plants for
possible inclusion in
pharmacologic studies.
More plants are being screened
for possibly effectiveness in
treating malaria, dengue fever,
and tuberculosis

No. 113
HERBAL MEDICINE
entegrated
Institute Research
of Traditional
Program
and Alternative
on MedicinalHealth
PlantsCare
(NIR(
What is the
PITAHC?
A government owned and controlled
corporation (GOCC) in association with
the DOH
Answers the present needs of the people
on health care  provision and delivery
of traditional and alternative health care
(TAHC) products, services and
technologies that have been proven
safe, effective and affordable
Lim, Vanessa Class No. 2
HERBAL MEDICINE
e Institute of Traditional and Alternative Health Care

VISION-MISSION of
PITAHC
VISION:
"Traditional and alternative health
care
in the hands of the people"
MISSION:
"PITAHC upholds the right of every
Filipino
for better health through the
provision of safe, effective and
affordable traditional and
alternative health care products,
HERBAL MEDICINE
Introduction History The 10 DOH Herbal Medicines Potential
Harmful Herb-Drug and Herb-herb Interactions
President GMA's 2007

SONA
quest for cheaper medicines
through parallel importations without
complementary support for
developing our own drugs,
including alternative or herbal
medicines
Palma, Sharlene Mae S. Class

No. 132
HERBAL MEDICINE
10 Medicinal Plants
(Feria.DR.
2007)
JAIME GALVEZ-TAN
- former director of the National Institutes of
Health (NIH)
- president of Health Futures Foundation Inc.
Health research and development over

the past 30 years has focused on only 10
medicinal plants.
about P20 million to complete necessary

chemical and clinical tests on one plant
at least P200 million for the research and

development of a new batch of herbal
No. 132
HERBAL MEDICINE
10 Medicinal Plants
(Feria. 2007)
Philippine Council for Health
Research and Development (Jaime
Montoya, executive director)
• coordinates and helps fund studies in
alternative medicine
Eight new ongoing research

projects
• four involve plants on the old-10 list but for
new uses
Sambong
Ulasimang bato Palma, Sharlene Mae S. Class
No. 132
HERBAL MEDICINE
This is the list of the 10

medicinal plants that the DOH
endorsed through its
"Traditional Health Program"
All 10 herbs have been
thoroughly tested and clinically
proven to have medicinal value
in the relief and treatment of
various ailments.

No. 132
HERBAL MEDICINE
THE LIST
1. Akapulko (Cassia alata)
2. Ampalaya (Momordica charantia)
3. Bawang (Allium sativum)
4. Bayabas (Psidium guajava)
5. Lagundi (Vitex negundo)
6. Niyog-niyogan (Quisqualis indica L.)
7. Sambong (Blumea balsamifera)
8. Tsaang Gubat (Ehretia microphylla Lam.)
9. Ulasimang Bato /Pansit-pansitan
(Peperomia pellucida)
10. Yerba Buena (Clinopodium douglasii)

No. 132
HERBAL MEDICINE
AKAPULKO (Cassia alata)
abundant throughout
the Philippines
“Bayabas-
bayabasan" and
“Ringworm bush“
The plant is six feet in

height belonging to
the legume family.
No. 132
HERBAL MEDICINE

Active substance: Chrysophanic acid
toxic to cattles
Saponin content of leaf extract

laxative useful in expelling intestinal
parasites
toxic in rats
Toxic effects
chronic diarrhea, loss of appetite,
weight loss (in rats)
No. 132
HERBAL MEDICINE
In-vitro studies : high anti-

fungal activity on dermatophytic
fungi
low activity on non-dermatophytic

fungi
plant water extract was also

reported to have anti-fungal activity
against Candida albicans, and
even anti-bacterialPalma,
activity against
Sharlene Mae S. Class
No. 132
HERBAL MEDICINE
Bioactivity studies on Cassia alata

Linn. leaf extracts (Villaseñor, et.
al. 2002)
5 mg/20 g mouse  the hexane
extract was analgesic
5 mg/20 g mouse  hexane and
EtOAc (Ethyl Acetate)extracts
exhibited anti-inflammatory activity
with a 65.5% and 68.2% decrease
in carrageenan-induced
inflammation, respectively
No. 132
HERBAL MEDICINE

2 mg/20 g mouse extract was
antimutagenic with a 65.8% inhibition
in the mutagenicity of tetracycline
50 mg/mL hexane most active
against Trichophyton mentagrophytes,
at a concentration of but it had no
activity against Candida albicans.
EtOAc extract  more active against
C. albicans.
hypoglycemic at a
dosage of 5 mg/20 g mouse,decreased
the blood sugar level
Palma,by 58.3%
No. 132
HERBAL MEDICINE
AMPALAYA (Momordica charantia)

“Bitter gourd” or
“Bitter melon”
Treatment of
Diabetes Mellitus
(non insulin
dependent)
Fruit is used
Contraindications:
Individuals with liver
disease, pregnant women
No. 132
HERBAL MEDICINE
Active constituents:
- sterols (charantin)
- triterpenes (momorcharaside
A and
momorcharaside B)
- proteins (momorcharin A and
B, MAP-30)

No. 132
HERBAL MEDICINE
Contains flavanoids and alkaloids

make the Pancreas produce more
insulin
Good source of vitamins A, B and C,

iron, folic acid, phosphorus and
calcium
Hypoglycemic effect: insulin

secretagogue No.
effect;
132
Palma,insulin like
HERBAL MEDICINE
Reduces hepatic cholesterol

and triglyceride in a dose
dependent manner
MAP30 (anti-HIV plant protein)
– acts on some stages in viral
cycles in acute and chronic
infections

No. 132
HERBAL MEDICINE
Anti-diabetic potentials of
Momordica charantia and
Andrographis paniculata and
their effects on estrous
cyclicity of alloxan-induced
diabetic rats (Reyes, et. al.
2005)
The blood glucose levels in the

groups usedNo.in132the
Palma,study were
HERBAL MEDICINE
An Inquiry to the Hypoglycemic

Action of Momordica charantia
Among Type 2 Diabetes Patients
(Rosales and Fernando. 2001)
Ampalaya fruit prepared as a tea can

be a useful dietary adjunct in the
treatment of diabetes. It is well
tolerated and safe with minor
gastrointestinal side effects
particularly increased bowel
movement No. 132
HERBAL MEDICINE
The effect of Momordica charantia

capsule preparation on glycemic
control in Type 2 Diabetes Mellitus
needs further studies (Dans, et. al
2006)
More RCT’s with a bigger sample size

should be made because results are
inconclusive

No. 132
HERBAL MEDICINE
BAWANG (Allium sativum)

Hypertension - reduces
cholesterol in the blood
and hence, helps control
blood pressure
Fresh bulbs are the main

part utilized for its
therapeutic effect
primary active compound

in garlic is Allicin
(derived from cysteine)
No. 132
HERBAL MEDICINE
Evaluation of Safety and Efficacy The 10 DOH Herbal Medicines Potential Ha
Herb-Drug and Herb-herb Interactions
Therapeutic effects:
Antihypertensive,
Anticholesterolemic,
Antilipidemic,
Reduces platelet
aggregation,
Vasodilator,
Expectorant,
Antihistaminic,
Antimicrobial
No. 132
HERBAL MEDICINE

Medicinal plants for toothache
relief
(Marasigan, et. al 2000)
The efficacy of crude ethanolic and

aqueous extracts of guava, yerba-
buena, avocado, bawang and
calachuchi in inhibiting the growth of
Lactobacillus acidophilus
Antibacterial activity was determined

by paper disc-agar plate method of
assay No. 132
HERBAL MEDICINE
BAYABAS (Psidium guajava)
Used as an antiseptic,
to disinfect wounds
mouth wash: tooth
decay and gum
infection
Rich in tannins, phenols,
triterpenes, flavonoids,
essential oils, saponins,
carotenoids, lectins,
vitamins, fiber and fatty
acids Palma, Sharlene Mae S. Class
No. 132
HERBAL MEDICINE
Other flavonoids and triterpenes in

guava leaves show antispasmodic
activity
Polyphenols (leaves) – antioxidant;

Bark and leaf extracts -
antibacterial properties
antifungal, anti-yeast (candida),
anti-amebic, and anti-malarial
actions No. 132
HERBAL MEDICINE
A Comparative Study on the

Drying Effects of Guava
Decoction, 70% Isopropyl
Alcohol and Water on Umbilical
Cords of Newborns, An In Vitro
Experimental study (Dacumos.
2008)
Guava decoction double strength has

better drying properties (percentage
decrease in weight cord) compared to
distilled water and 70% Green Cross
No. 132
HERBAL MEDICINE
LAGUNDI (Vitex negundo)

relief of coughs and
asthma
endorsed by the DOH

as effective in the
treatment of colds,
flu, and pharyngitis
prevent the body's
production of
leukotrienes
No. 132
HERBAL MEDICINE

Chrysoplenol D: smooth muscle
relaxant with anti-histamine properties
Isoorientin
Casticin
Luteolin-7-0-glucoside – anti-histamine
effect
Inhibit leukotriene release
National Integrated Research Program on Medicinal Plants, DOST

No. 132
HERBAL MEDICINE

Main constituents are volatile oil,
resin, alkaloid, lichen acids and
glucoside
May be used as a leaf decoction for

fever, headache,
toothache
analgesic and antitussive
(prepared as a pleasant tasting cough
syrup)
No. 132
HERBAL MEDICINE

Replacement for
Dextromethorphan in public
health systems
Reduces coughing and relaxes

bronchial smooth muscles
Lagundi is one of the few herbs

recently registered with the Bureau
of Foods and Drugs (BFAD) as
medicines Palma, Sharlene Mae S. Class
No. 132
HERBAL MEDICINE
NIYOG-NIYOGAN (Quisqualis indica L.)

“Chinese honey
suckle”
seeds are utilized for

its therapeutic effect;
dried seeds are
preferred
Chemical
components of seeds
include quisqualic
Balan, Ralph Class No. 03
acid (active
HERBAL MEDICINE
NIYOG-NIYOGAN (Quisqualis indica L.)

Uses
Adverse Effects
Antihelminthics
diarrhea, abdominal pain,
(ascariasis)
distention and hiccups,
alleviation of nephritis
especially if the seeds are
remedy for boils and
eaten
ulcers fresh or continuously
for consecutive
relief days
from ache caused
by fever
treatment of rheumatism
HERBAL MEDICINE
SAMBONG (Blumea balsamifera)
also known as
“Camphor”
high in essential oils,

and contains significant
amounts of camphor
oil
commonly used in
capsule form or as teas Balan, Ralph Class No. 03
HERBAL MEDICINE
Diuretic that helps in the excretion

of
urinary stones
Anti-urolithiasis
Hypertension
Mild to moderate congestive
heart failure
HERBAL MEDICINE
THE PHILIPPINE CLINICAL PRACTICE

GUIDELINES ON THE DETECTION AND
MANAGEMENT OF HYPERTENSION
Report of the Multisectoral Task Force on the
Detection and Management of Hypertension
Convened by the Philippine Society of
Hypertension (Phil. J. Internal Medicine,
35:67-85, March-April, 1997)
No indigenous herbal preparations have

been adequately tested for its
antihypertensive effect
HERBAL MEDICINE

Among the many herbal preparations
being speculated as having anti-
hypertensive properties, only
“sambong” is undergoing a rigorous
evaluation.
At present, a randomized, double-

blind crossover study is ongoing to
test the efficacy of this herbal medicine
among mild hypertensiveness
[reference unpublished].
HERBAL MEDICINE
TSAANG GUBAT (Ehretia microphylla Lam.)

“Wild Tea”, “Forest
Tea”, “Alibungog”
(Visayas Region),
“Putputai” (Bicol
Region) and Maragued
(Ilocos Region)
available commercially in
capsules, tablets and tea
bags
BFAD registered as an herbal Balan, Ralph Class No. 03

medicine
HERBAL MEDICINE
antispasmodic for abdominal

(stomach) pains
high fluoride content – mouthwash;

effective in treating intestinal
motility
Active compounds are triterpenes

HERBAL MEDICINE
Uses
Gastroenteritis
Dysentery
Diarrhea or Loose Bowel
Movement (LBM)
Body cleanser/wash

HERBAL MEDICINE

Dr. Gerard Penecilla
- pharmaceutical scientist of the National
Council of the Philippines (DOST)
Yeast Bioassay
- to determine pharmacologic activities
(anticancer) of medicinal plants
Tsaang Gubat
-high potential in fighting growth and
multiplication activities of cancer cells
Philippine Star , 18 July
2008

HERBAL MEDICINE
Ulasimang Bato /Pansit-pansitan

“Olasiman-ihalas” &
“Tangon-tangon” in the
Philippines
English name: Peperomia
Small herb that grows from 1

to 1 1/2 feet, leaves and
stalk are edible

HERBAL MEDICINE

main components are Dillapiole

(39.7%) and
Trans-caryophyllene (10.7%)
Apiole, a phenolic ester, may stimulate

uterine contractions and also
hepatotoxic
as a salad, helps relieve rheumatic

pains and gout Balan, Ralph Class No. 03
HERBAL MEDICINE

Uses
skin disorders (abscesses,
pimples and boils)
leaves and/or stalks boiled and
pounded then applied directly to
the afflicted area
Infusion or Decoction:
boil 1 cup of leaves/stem in 2
cups of water and taken twice a
day
HERBAL MEDICINE
YERBA BUENA (Clinopodium douglasii)

Herb of the mint family
&
commonly known as
Peppermint
Primary active component

is menthol responsible
for antispasmodic,
antiseptic, carminative,
anesthetic, and choleretic
properties
HERBAL MEDICINE
YERBA BUENA (Clinopodium douglasii)

Main components
volatile peppermint oil, composed of
50-78% menthol and 5-20%
menthol esterfied with various
organic acids, such as acetic and
bovaleric
Other important components include
flavonoids (luteolin, menthoside),
phenolic acids, and triterpenes
HERBAL MEDICINE
HERBAL PLANT CLINICAL USE

Akapulko Antifungal
Ampalaya NIDDM
Bawang Antihyperlipidemic
Bayabas Antiseptic
Lagundi Asthma/Cough
Niyog-niyogan Antihelminthic
Sambong Diuretic
Tsaang gubat Antispasmodic
Ulasimang-Bato Rheumatism/Gout
Yerba Buena Antiseptic/Antispasmodic

HERBAL MEDICINE
Other Commonly Used Herbal Medicines

in the Philippines
Not approved by regulatory
agencies such as the Philippine
BFAD or the US FDA
In general, due to lack of

pharmacologic and toxicologic data,
avoid use in pregnancy
Evidence of effects sometimes

anecdotal Balan, Ralph Class No. 03
HERBAL MEDICINE
Other Commonly Used Herbal Medicines

inPlant
the Philippines
Uses
Banaba Non-insulin dependent diabetes
Luya/Ginger cold, cough, fever, sore throat,

(Zingiber lowering cholesterol levels, nausea
and vomiting; anti-fungal, anti-
officinale) viral, and anti-inflammatory
properties
Sabila (Aloe moisturizing and hydrating the
barbardensis) skin; supposed anti-oxidant effect
when ingested (anti-hypertensive
effects as well as for arthritis and
Ginseng (Panax diabetes)
improved physical and cognitive
ginseng) performance, mood, and
metabolism, Additive anti-
coagulant effect if used with
warfarin Balan, Ralph Class No. 03
HERBAL MEDICINE
Usual Formulations Available for

Herbal Preparations
or External Applications
• Expressed
Semi-solid
Semi-solid
Liquid from
mixture
or Semi-liquid
semi-liquid
• Ointments leaves, flowers
preparation
of paraffin orwithof
plants/herbs
one
mucilages
or more asand
herbal
the
• Oils • Applied
peels on intact
skin
of fruits,
medicaments
base and finely
mostly
skin with
without citrus fruits
friction
friction
dissolved or
powdered herbal
• Lotion •
• Diluted
Mixturesbefore
dispersed
medicaments ofinOils
Oils,
applied topically
• suitable
Creams
External base
and
use only
• Liniments • For massage,
• Glycerin
• Applied
More of on skin mild
powdered
aromatherapy, and
mucous
astringent,
herbs than base
• Pastes
• carminative,
Base +
stimulant, anti-septic
Essential/Herbal Oils Maulion, Marienelle R. Class
No. 66
HERBAL MEDICINE
Usual Formulations Available for

Herbal Preparations
For Oral Intake • Concentrated
• Elixirs •
• Aromatic
Expression
Ground-powdered
Dilute liquid
solutionsfromof
solutions
preparation
fresh or of sucrose
dried with
fruits, flowering
water-soluble
• Capsules • high
Sweet
herbs proportion
vehicle of
for
herbal extracts in
tops, contained
leaves
alcohol,
hard
nauseous or glycerin
soft gel
herbal
• Juices • Maceration
Taken
and immediately
propylene for
capsules
medicines
after
varying
glycol extraction
short
• Infusions • Easily swallowed,
• Higher sucrose
periods
• Can
For of time
be stored
potent
tasteless or and (5
concentration
mins to 2 hours)for
• Syrups • nauseous
refrigerated
Very popular
preservation
herbal
into
of
medicaments
• Herbs
tightly
consumers sealed bottle
enclosed in
herbal extracts
cloth and
suspended
Maulion, Marienelle R. like a Class
No. 66
HERBAL MEDICINE
Herbal
Therapies + = possible
dangerous side
effects and/or
Prescription and reduced benefits
Non- from the
medications
prescription
HERB-DRUG INTERACTIONS
Medications
Herbal therapies and drugs can interact
in the body, causing changes in the
way the herbs and/or drugs work.
Interactions can be beneficial or
harmful. Class No. 69
Medina, Kristianne Rachel P.
HERBAL MEDICINE
Very little is known about herb-

drug interactions
Research on herbal therapies is not nearly as
advanced as research on drugs
Herbal studies are not studied or monitored
for safety and potential interactions
Herbal products have not been regulated for
purity and potency
Sources of
information
– anecdotal – in vitro studies
information – observational
– clinical studies
experience – pharmacokinetic
– case reports Medina,studies
Kristianne Rachel P.
Class No. 69
HERBAL MEDICINE
Dietary Supplement Health and Education Act

of 1994 (DSHEA)
DIETARY SUPPLEMENT
-a product (other than tobacco) that is
intended to supplement the diet that bears
or contains one or more of the following
dietary ingredients: a vitamin, a mineral,
an herb or other botanical, an amino acid, a
dietary substance for use by man to
supplement the diet by increasing the total
daily intake, or a concentrate, metabolite,
constituent, extract, or combinations of these
ingredients
- not subject to premarket safety

evaluations Class No. 69
HERBAL MEDICINE
Labeling of Dietary
Supplements
Claims to prevent, treat, or cure a specific disease
are expressly prohibited.
Statements describing the supplement's effects on

the "structure and function" or general "well-being"
of the body are allowed, as long as they are truthful
and should bear the statement "This statement
has not been evaluated by the Food and Drug
Administration. This product is not intended to
diagnose, treat, cure, or prevent any disease.“
The product label must identify the product as a

dietary supplement.
- Dietary Supplement Health and
Class No. 69 Education Act of 1994
HERBAL MEDICINE
Who is at risk of herb-drug

interactions?
Populations most susceptible to
interactions
Patients with Cardiac or CVD disease
Take drugs with narrow therapeutics
windows
Anticoagulants, cardiac glycosides
Elderly
Chronic drugs
Diabetics
Effects on glucose control
Secondary problems warranting
Medina, drug
Kristianne Rachel P.
therapy Class No. 69
HERBAL MEDICINE
Who is at risk of herb-drug

interactions?
Significant risk for patients
Immunosuppressives
cyclosporine
Anticoagulants
Warfarin
Protease inhibitors (AIDS)

Class No. 69
HERBAL MEDICINE
Pharmacokinetic
Interactions
Absorption
a herb/drug that alters the stomach pH (anti-acids) or
intestinal motility (laxatives)
Metabolism
duration of an herb or drug in the body depends on whether
the liver’s
metabolism is induced or inhibited
Elimination
affected by the individual’s kidneys function or by drugs’
toxic side effects
Health condition, age, body weight,

metabolic rate and
Class No. 69 dosage
HERBAL MEDICINE
Pharmacodynamic
Interactions
Substances may interact by direct
chemical action with each other, either
before ingestion, or while mixed
together in the stomach and intestines.
Herb and drugs may work together

(synergistically) or in opposition
(antagonistically).
Difficult to predict or prevent

Class No. 69
HERBAL MEDICINE
Herb-Drug and Herb-Herb

Decreased bioavailability Increased bioavailability
Interactions
of drug of drug
↓ Absorption ↑ Absorption
fibers Ginger
mucilage herbs Cayenne
↑ p- Black Pepper
glycoprotein ↓ Metabolsim
↑ Metabolism ↓ CYP 450
↑ CYP 450 Grapefruit Juice
↑ Elimination ↓ Elimination
laxative herbs Licorice- anti-
diuretic herbs diuretic
Class No. 69
HERBAL MEDICINE

Interactions
Potentiation of drug via similar activity
Drug diuretic and herb diuretic
Potentiation of drug via complementary
activity
↓ P-glycoprotein system (Eluthero and
antibiotics)
Bitter melon, gymnema, fenugreek and
insulin or oral hypoglycemics
Decreased effectiveness of drug via
antagonistic activity
CNS stimulant with CNS depressant
Reduced side effects of drug
Milk Thistle and hepatotoxic drugs
Licorice and corticosteroids
Class No. 69
HERBAL MEDICINE

Interactions
Bromel
ain
May ↑ bleeding with
anticoagulants
May ↑ effects of
antibiotics
↑ efficacy of
vincristine and 5-
fluoroiuracil
Class No. 69
HERBAL MEDICINE

Interactions
Cayen
ne
↑ metabolism of drugs
by enhancing absorption
(↑ bioavailability)
↓ gastric mucosal
damage when taken 30
minutes before ASA
Aggravates ACE inhibitor

cough and reduces drug
action
Class No. 69
HERBAL MEDICINE

Interactions
Ephed
ra
Additive effect on
neurotransmitter levels
with MAO inhibitors
↓ drug performance of
beta blockers, may cause
arrythmias or BP elevation
↑ steroid drug clearance

thus, reducing therapy
effectiveness
Class No. 69
HERBAL MEDICINE

Interactions
Garl
ic
May ↑ bleeding times with
anticoagulants risk of
spontaneous and post-op
bleeding
↓ blood levels of protease

inhibitors
↑ indomethacin, insulin,
statins
Preparations containing Medina, Kristianne Rachel P.

allicin may increase the
Class No. 69
HERBAL MEDICINE

Interactions
Ging
er
May ↑ absorption of drugs
↑ bioavailability
Synergistic with anticoagulants, possible ↑
coagulation
May ↑ cholesterol lowering effects of statins
Reduces after-effects of general anesthesia
(↓ N & V)
Case reports of ↓ effect of antacids
(heartburn)
Class No. 69
HERBAL MEDICINE

Interactions
Ging
ko
May ↑ spontaneous and post-op
bleeding with anticoagulants, ASA
and general anesthetics
May ↑ activity and side effects of

MAO inhibitors
May ↑ efficacy (potency) of
haloperidol in schizophrenia
(study)
↑ nifedipine plasma levels

Class No. 69
HERBAL MEDICINE

Interactions
Ginse
ng
Potentiation when taken with
anticoagulants
↑ alcohol metabolism leading
to ↑ clearance
Synergistic with insulin,
improves diabetic symptoms
Synergistic with influenza
vaccine, reduces flu
symptoms, frequency and
severity
Class No. 69
HERBAL MEDICINE

Interactions
Green
Tea
Inhibits absorption of codeine or
theophylline
May ↓ effect of coronary

vasodilator drugs
Synergistic with sulindac and/or
tomaxifen, ↓ adverse effects
Contains vitamin K, thus, can
render warfarin ineffective
Should not be mixed with aspirin

because they both prevent Medina, Kristianne Rachel P.
platelets from clotting
Class No. 69
HERBAL MEDICINE

Interactions
Take the herbs and the drugs at different
times of day, or at least separated by
many hours.
Just because it’s natural does not

mean it is harmless.
Knowledge is the best defense

against
drug-herb and herb-herb interactions.
Remember that no
Class No. 69 drug or herb has
HERBAL MEDICINE
Introduction
Laws Collection,
HistoryProcessing andThe
Manufacturing
10 DOH Herbal Medicines
WHO GuidelinesPotential
on GoodHarmfu
Agricu
and Herb-herb
Practices Interactions
Proclamation
No. 698 19, 2004, Pres. Gloria Macapagal-
On August
Arroyo declared the month of November as
Intrinsic
“TRADITIONAL &
Genetic factors
Growth ALTERNATIVE
HEALTH MONTH”
Characteristics
to promote and be able to provide an array of

adorable, accessible and effective traditional and
complementary / alternative health care options
for our people to choose from
to accelerate the development of traditional and
alternative medicine for the good of our people
HERBAL MEDICINE
Laws Collection, Processing and Manufacturing WHO Guidelines on Good Agricu
Practices
BA
2008-
BFAD Health Advisory on January 16, 2008
002
Immediate Recall of Penrex Herbal
Supplement For Men
It was found to contain Sildenafil Citrate, a

component dangerous to persons with heart
ailments
Classified as herbal supplement, so it should

not contain any active ingredient for drug
products

HERBAL MEDICINE
Practices
BA
2001-
BFAD Health Advisory on March 26, 2001
001
Warning on the use of Glo-herbal
drink/products
It is NOT REGISTERED with the

Bureau NOR ALLOWED TO BE
ADVERTISED OR PROMOTED FOR
ANY THERAPEUTIC INDICATION.
manufacturer of said products have not
submitted scientifically valid proofs to show
and substantiate the therapeutic effects
that are being claimed for the products
HERBAL MEDICINE
Laws Collection, Processing and Manufacturing WHO Guidelines on Good
Agricultural Collection Practices
BA
2000-
BFAD Health Advisory on September 1, 2000
006
Warning on the use of “CURE-
ALL” products
Adverse events being associated with the use
of some “cure all” products such as the "PDA
Water" from Tarlac City, Mahogany seeds and
other herbal preparations have been reported.
Products that are being promoted as "cure-

all" do not have any scientific basis of
safety and efficacy Lim, Vanessa Class No. 2
HERBAL MEDICINE
Laws Collection, Processing and Manufacturing WHO Guidelines on Good
Agricultural Collection Practices
ant Guidelines in Taking Herbal Medicine

Factors Affecting Safety and Quality
Control of Raw Materials
Intrinsic Extrinsic
Genetic factors Environment
Growth Collection methods
Characteristics
Cultivation
Harvest
Post-harvest
Processing
Transport
Storage practices
Macasaet, Aelleen P. Class

No. 44
HERBAL MEDICINE
Practices
uidelines on Good Agricultural Collection Practices
Reasons for Formulation of

the Guidelines:
Increase in use of herbal medicines
worldwide
Increase in reports of adverse

effects
Insufficient attention paid to the

quality assurance and control of
herbal medicines
No. 44
HERBAL MEDICINE
Practices
uidelines on Good Agricultural Collection Practices
STRUCT
URE
Section 1: General Introduction
Section 2: Good agricultural practices for
medicinal plants
Section 3: Good collection practices for
medicinal plants
Section 4: Common technical aspects of good
agricultural practices for medicinal plants
and good collection practices for
medicinal plants No. 44
HERBAL MEDICINE
Practices
Sectio
n2Identification/authentication of
cultivated medicinal plants
• Selection of Medicinal Plants
Consult national pharmacopoeia or
authoritative national documents
of the end-user's country or that of
other countries

No. 44
HERBAL MEDICINE
Practices
Sectio
• Selection of Medicinal Plants
– Consult national pharmacopoeia or
authoritative national documents of
the end-user's country or that of
other countries
– Newly introduced plants
• Species/botanical variety used in
traditional medicine of the original
country

No. 44
HERBAL MEDICINE
Practices
Sectio
• Botanical Identity
– Scientific name
• Genus, Species,
subspecies/variety, Author,
Family
– Local and English common names
if available
– Others (e.g. Cultivar) as
appropriate
No. 44
HERBAL MEDICINE
Practices
Sectio
n2Seeds and other
propagation materials
• Specified
• Provide information
– Identity, Quality, Performance,
Breeding history
• Of best quality

No. 44
HERBAL MEDICINE
Practices
Sectio
n2Cultivat
ion
• Intensive care and management
• Different plant materials vary in
conditions and duration
• Should have a basis
– Scientifically published
– Traditional methods
– Research
• Apply Conservation Agriculture (CA)
techniques
– Prevent build-up of organic matter
– Conserve soil humidity
No. 44
HERBAL MEDICINE
Practices
Sectio
n2Harv
est
• Optimal season or time period
• Depends on the plant part to be
used
• Should have a basis
N.B. Best time of harvest based on

the quality and quantity of
biologically active constituents
not on the total vegetative yield.
No. 44
HERBAL MEDICINE
Practices
Sectio
n2Person
nel
• Adequate knowledge
• Maintain appropriate personal
hygiene
• Apply agrochemicals: wear
appropriate protective clothing
• Receive instruction on proper
agricultural stewardship

No. 44
HERBAL MEDICINE
WHO General
Laws Strategies
Collection,
and Methods
Processing
for Collection
and Manufacturing
of Fresh Medicinal Plants
WHO Guidelines
WHOon Post
GoodHarvest
Agricu
Processing
Practices
ral Strategies and Methods for Collection of Fresh Medicinal Plan
Permission to
Collect
Need to procure permission
prior to collect
Collection permits and related
documents (government and
landowners)
National “red” lists
Export from country of origin –
permits also
Nallas, Anna Pauline R.
Class No. 91
HERBAL MEDICINE
WHO General Strategies and Methods for Collection of Fresh Medicinal Plants WHO Post Harvest
Processing
Technical
Planning
“Geographical distribution and
population density” of any medicinal
plant
Location of the collection area from the

home base and the quality of the plant
after being transported
Research and the Team: Personnel and

Transportation
Social and Ecological Impact
Class No. 91
HERBAL MEDICINE
Processing
Selection of Medicinal Plants

for Collection
“National Pharmacopoeia” or those
recommended by other “authoritative national
documents” for the target country
Sufficient identification, documentation and

description of the plant (traditional medicine)
Prepare and submit botanical specimens to the

“regional or national herbaria” for
authentication
“Recorded and maintained” for identification

Class No. 91
HERBAL MEDICINE
Processing
Collect
ion
“Long-terms survival of wild populations and
their associated habitats”
Demographic structures
Government and environmental authorities
ensure the continuous cultivation
Best possible quality, Best time of collection
Ecologically non-destructive systems
Location caution
Proper collected and packed, Preliminary
processing
Class No. 91
HERBAL MEDICINE
Processing
Person
nel
Experts
Full documentation
Botanical training
Instructions  protection, sustainability,
maintenance
Knowledgeable links
Welfare and safety
Protect personnel  clothing and health

Class No. 91
HERBAL MEDICINE
Processing
Post
Harvesting
Inspection and sorting
visual inspection for cross-
contamination
visual inspection for foreign
matter
Evaluation
Appearance
free from contamination and
decomposition
Storage and Transportation
ensure their integrity
Ong, Maynard Ivan F. Class No.
110
HERBAL MEDICINE
Processing
Processi
ng
Drying
moisture content kept as low as
possible
reduce damage from mould and
other microbial infestation
temperature and humidity should
be controlled
Methods
In the open air (shaded from direct
sunlight)
Direct sunlight, if appropriate
110
HERBAL MEDICINE
Processing
Processi
ng
Indirect fire
Drying ovens/rooms and solar
dryers
Baking
Lyophilization
Microwave or infrared devices

110
HERBAL MEDICINE
Processing
Specific
Processing
To improve the purity
Enhance efficacy
Reduce time of processing
Reduce damage due to
environment exposure
Methods
pre-selection
peeling the skins of roots and
rhizomes
110
HERBAL MEDICINE
Processing
Specific
Processing
boiling in water
steaming
soaking
pickling
distillation
fumigation
roasting
natural fermentation
treatment with lime and chopping

110
HERBAL MEDICINE
Processing
Processing
Facilities
Location
– Accessibility
– Drainage
– Odors ,smoke, dust
Building
– Design and layout of station
areas
– Construction materials
– Environment control
110
HERBAL MEDICINE
Processing
Handling
Areas
Construction considerations
Preventing accumulation of
dirt, moulds, and general
cleanliness
Objective
Preventing contamination
Preserving their therapeutic
integrity
Provide minimal alterations to
their physical110 or chemical
HERBAL MEDICINE
Processing
Other
Considerations
Water Supply
Effluent and Waste Disposal
Changing facilities and Toilets
Hand-washing and
disinfection facilities
Lighting
Ventilation
Bulk packaging and Labeling
110
HERBAL MEDICINE
Processing
Storage and
Transportation
Materials
Identification
Quality Assurance
Documentation
Personnel

110
HERBAL MEDICINE
WHO
Evaluation
Generalof
Strategies
Safety and
and
Efficacy
Methods for Collection of Fresh Medicinal Plants WHO Post Harvest
Processing
ssification of Herbal Medicines
World Health Organization (WHO)

• Guidelines for the regulation of
herbal medicines in the South-
East Asia Region
• based on origin, evolution and
the forms of current usage
assessment of the ways in which quality,
safety and efficacy of these medicinal plants
can be determined and further improved
Madulara, Glaiza M. Class
No. 47
HERBAL MEDICINE
Evaluation of Safety and Efficacy
ssification of Herbal Medicines

Category 1 --- Indigenous herbal medicines
• historically used medicinal plants in a local
community or region
Category 2 --- Herbal medicines in systems
• used for a long time and officially documented
with their special theories and concepts
Category 3 --- Modified herbal medicines
• modified medicinal plants
• shape, form, dose, dosage form, mode of
administration, herbal medicinal ingredients,
methods of preparation and medical indications
Category 4 --- Imported products with a herbal
medicine base
• all imported herbal medicines
No. 47
HERBAL MEDICINE
ements for Assessment of Safety of Herbal Medicines
SAFE
causes no known or potential harm to
user
Categories of Safety
WHO
To determine the nature of the safety

requirements that would have to be
ensured
Three categories
No. 47
HERBAL MEDICINE
ements for Assessment of Safety of Herbal Medicines

Three Categories of Safety:
Safety Category 1
• safety is well-established due to use over
long time
Safety Category 2
• safe under specific conditions of use
Safety Category 3
• uncertain safety
• the safety data required for this class of
drugs will be
identical to that of any new substance
No. 47
HERBAL MEDICINE
Data Gathering
Guidelines for Toxicity Investigation of

Herbal
Medicines
General Guidelines for Methodologies on Research and
Evaluation of Traditional Medicine by the WHO
Specify the standard methods of toxicological studies
assessing the safety and efficacy of herbal medicines
Two Main Toxicity Tests used in the study

of herbal medicine
Acute toxicity studies
necessary for any pharmaceutical intended for human use
Long term toxicity test

observe symptoms, herbal actions and toxicity after
prolonged treatment
No. 47
HERBAL MEDICINE
Data Gathering
Acute-Toxicity Long-term Toxicity
Testing Testing
Animal species Animal species
At least two species: rodents AND At least two species: rodents AND
non-rodents non-rodents
Sex Sex
In at least one of the species, Same number of male and female
males and females should be used. animals should be used
Number of animals
Number of animals Rodents
Rodents at least 10 males and 10
at least five animals per females
gender Non-rodents
Non-rodents at least 3 males and 3 females
at least two animals per
gender. Route of administration
oral route
Route of administration
oral route - normal route of clinical parenteral route of administration
administration
parenteral route of administration Madulara, Glaiza M. Class
No. 47
HERBAL MEDICINE
Data Gathering
Acute-Toxicity
Testing
Dose levels
Rodents
Verify the approximate lethal dose
non-rodents
Observation of overt toxic signs.
Frequency of administration
Test substance should be administered in one/more doses
during a 24-hr period.
Observation
Observed and recorded in relation to dose & time
Toxic signs
Severity, onset, progression and
Reversibility of the signs
Observed for at least 7 - 14 days
Dead and surviving animals
should be autopsied, histopathological examination
No. 47
HERBAL MEDICINE
Data Gathering Expected Period of Administration period

Long-term Toxicity Clinical Use for the Toxicity Study
Testing
Single Administration 2 weeks – 1 month
or Repeated
Administration Administration
period for < 1 week
• test substance Repeated 4 weeks – 3 months

Administration,
should be between 1 – 4 weeks
administered 7 days a
week. Repeated 3 – 6 months
Administration,
• the commonly used between 1 – 6 months
ranges of
administration periods Long-term repeated 9 – 12 months
administration for > 6
 months

No. 47
HERBAL MEDICINE
ablishment of Safety and Efficacy

Safe
ty
Guiding principle in the assessment of safety
when the product has been traditionally
used without
demonstrated harm
Lack of any reported or documented side-
effects
not an absolute assurance of safety for
herbal medicines
Additional toxicity studies must be
performed only when
doubts about its safety
no documentation of long historical use
in-vitro studies -- preferred
in-vivo study -- conducted humanely
No. 47
HERBAL MEDICINE
ablishment of Safety and Efficacy

Effica
cy
Requirements for proof of efficacy --
supporting documentation
Well-established, randomized controlled

clinical trials
provide the highest level of evidence for
efficacy
designed to determine the efficacy and safety of
the product under normal conditions of use

No. 47
HERBAL MEDICINE
Herbal Medication Quality Assurance and Promotion in the Philip
Quality assurance and control measures

National quality specification and standards for herbal
materials, good manufacturing practices (GMP) for
herbal medicines, labeling, and licensing schemes for
manufacturing, imports and marketing
vital for ensuring the safety and efficacy of
herbal medicines
Weak regulation and quality control
may result in a high incidence of adverse reactions
attributable to poor quality of herbal medicines
Regulation and control of herbal products

Under the authority of the Bureau of Food and Drugs
(BFAD) of the DOH
Quality Assurance
BFAD
Once achieved  High promotion of the BFAD seal
of good quality to physicians
Madulara, and
Glaiza M. Class
pharmacists No. 47
HERBAL MEDICINE
THANK YOU.
University of Santo Tomas
Faculty of Medicine and Surgery
Department of Pharmacology
Seminar on
HERBAL MEDICINE
Balan, Lim, J., Lim, V., Macasaet, Madulara, Maulion, Medina, Nallas, Ong, Ongoco, Palma

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HERBAL MEDICINE

University of Santo Tomas

Traditional and Alternative

Lim, Maria Joane Faye C. Class No. 22

Lim, Maria Joane Faye C. Class No. 22

Lim, Maria Joane Faye C. Class No. 22

Lim, Maria Joane Faye C. Class No. 22

Lim, Maria Joane Faye C. Class No. 22

Alternative Health Care

Some of the modalities are reflexology,

Foods that have been prepared from

including preparation, propagation, processing,

They have strong ethical principles that they

They believe it is their duty to foster life in all

They also believe that Nature's laws must be

Lim, Maria Joane Faye C. Class No. 22

ntegrated Research Program on Medicinal Plants (NIR

systematize the study of medicinal plants in

ntegrated Research Program on Medicinal Plants (NIR

2. Need to discover new or better drugs

Ongoco, Renncee A. Class

ntegrated Research Program on Medicinal Plants (NIR

ntegrated Research Program on Medicinal Plants (NIR

Ongoco, Renncee A. Class

ntegrated Research Program on Medicinal Plants (NIR

ntegrated Research Program on Medicinal Plants (NIR

Ongoco, Renncee A. Class

e Institute of Traditional and Alternative Health Care

President GMA's 2007

Palma, Sharlene Mae S. Class

Health research and development over

about P20 million to complete necessary

at least P200 million for the research and

Eight new ongoing research

This is the list of the 10

Palma, Sharlene Mae S. Class

Palma, Sharlene Mae S. Class

AKAPULKO (Cassia alata)

The plant is six feet in

AKAPULKO (Cassia alata)

Saponin content of leaf extract

AKAPULKO (Cassia alata)

In-vitro studies : high anti-

low activity on non-dermatophytic

plant water extract was also

AKAPULKO (Cassia alata)

Bioactivity studies on Cassia alata

AKAPULKO (Cassia alata)

AMPALAYA (Momordica charantia)

AMPALAYA (Momordica charantia)

Palma, Sharlene Mae S. Class

AMPALAYA (Momordica charantia)

Contains flavanoids and alkaloids

Good source of vitamins A, B and C,

Hypoglycemic effect: insulin

AMPALAYA (Momordica charantia)

Reduces hepatic cholesterol

Palma, Sharlene Mae S. Class

AMPALAYA (Momordica charantia)

The blood glucose levels in the

AMPALAYA (Momordica charantia)

An Inquiry to the Hypoglycemic

Ampalaya fruit prepared as a tea can