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 Drug and Herb-herb Interactions The 10 DOH Herbal Medicines

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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
Introduction History Drug and Herb-herb Interactions The 10 DOH Herbal Medicines

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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.
Lim, Maria Joane Faye C. Class No. 22

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efinition of Terms

BIOMEDI CINE

A discipline of medical care advocating therapy with remedies that produce effects differing from those of the diseases treated.

Lim, Maria Joane Faye C.

Class No. 22

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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
Lim, Maria Joane Faye C. Class No. 22

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Introduction History Drug and Herb-herb Interactions The 10 DOH Herbal Medicines

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efinition of Terms

BIOMEDI CINE

Also called allopathy, western medicine, regular medicine, conventional medicine, mainstream medicine, orthodox medicine, or cosmopolitan medicine.

Lim, Maria Joane Faye C.

Class No. 22

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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,Joane Faye C. Lim, Maria applied Class No. 22

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efinition of Terms

HERBAL MEDICINE Medicines containing plant products Finished, labeled medicinal material(s) combined with active ingredient/s that contain as chemically-defined active or underground part/s of aerial substances, including chemically-defined, isolated plant or other materials or constituents of plants, combination thereof, whether in the crude stateconsidered to be are NOT or as plant preparations.

herbal medicines.

However, it may contain excepients in addition to the active ingredient(s).
Lim, Maria Joane Faye C. Class No. 22

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Introduction History Drug and Herb-herb Interactions The 10 DOH Herbal Medicines

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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
Lim, Maria Joane Faye C. Class No. 22

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Introduction History Drug and Herb-herb Interactions The 10 DOH Herbal Medicines

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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.
Lim, Maria Joane Faye C. Class No. 22

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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 Lim, Maria Joane Faye C. Class No. 22 disaster.

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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.

Lim, Maria Joane Faye C.

Class No. 22

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Introduction History Drug and Herb-herb Interactions The 10 DOH Herbal Medicines

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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. No. 113 Class

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Introduction History Drug and Herb-herb Interactions The 10 DOH Herbal Medicines

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ntegrated Research Program on Medicinal Plants (NIR 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.

Ongoco, Renncee A. No. 113

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ntegrated Research Program on Medicinal Plants (NIR 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 testedMUTAGENIC and not – HEAVY METALSRESIDUES Microbial counts AFLATOXIN PESTICIDE Harvested plant shouldn’t contain: approved (shouldn’t exceed WHO exceeding 100,000 TERATOGENIC
colony forming COMPOUNDS units
Ongoco, Renncee A. No. 113

leve

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ntegrated Research Program on Medicinal Plants (NIR To date, NIRPROMP has transferred the technology to pharmaceutical manufacturers for the production of 7 herbs in commercial form:

LAGUN DI HIERBA BUENA

SAMBON G

TSAANG GUBAT

A TI AMPALAY S A

ACAPULC O

Ongoco, Renncee A. No. 113

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Introduction History Drug and Herb-herb Interactions The 10 DOH Herbal Medicines

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ntegrated Research Program on Medicinal Plants (NIR 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 antidiabetic medicine developed by NIRPROMP.
Ongoco, Renncee A. No. 113 Class

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Introduction History Drug and Herb-herb Interactions The 10 DOH Herbal Medicines

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ntegrated Research Program on Medicinal Plants (NIR 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

Ongoco, Renncee A. No. 113

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e Institute Research Program Alternative Health Care ( ntegrated of Traditional and on Medicinal Plants (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

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Introduction History Drug and Herb-herb Interactions The 10 DOH Herbal Medicines

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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 Lim, Vanessa Class No. 2 alternative health care products,

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

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. No. 132

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10 Medicinal Plants (Feria. 2007) DR. 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 Palma, of herbal development of a new batchSharlene Mae S.
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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

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.
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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

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.
Palma, Sharlene Mae S. No. 132 Class

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

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

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

AKAPULKO (Cassia alata) abundant throughout the Philippines “Bayabasbayabasan" and “Ringworm bush“ The plant is six feet in height belonging to the legume family.
Palma, Sharlene Mae S. No. 132 Class

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

AKAPULKO (Cassia alata)
Active substance: Chrysophanic acid

toxic to cattles

Saponin content of leaf extract

laxative useful in expelling intestinal parasites toxic in rats chronic diarrhea, loss of appetite, weight loss (in rats)
Palma, Sharlene Mae S. No. 132 Class

Toxic effects

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

AKAPULKO (Cassia alata)

In-vitro studies : high antifungal 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 Palma, Sharlene against Class even anti-bacterial activity Mae S.
No. 132

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

AKAPULKO (Cassia alata)

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, respectivelyMae S. Palma, Sharlene
No. 132

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

AKAPULKO (Cassia alata) 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 by 58.3%S. Palma, Sharlene Mae Class
No. 132

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

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
Palma, Sharlene Mae S. No. 132 Class

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

AMPALAYA (Momordica charantia)

Active constituents: - sterols (charantin) - triterpenes (momorcharaside A and momorcharaside B) - proteins (momorcharin A and B, MAP-30)

Palma, Sharlene Mae S. No. 132

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

AMPALAYA (Momordica charantia)

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. 132 Palma,insulin like effect; Sharlene Mae S.

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

AMPALAYA (Momordica charantia)

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
Palma, Sharlene Mae S. No. 132 Class

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

AMPALAYA (Momordica charantia)

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. 132 Palma,studyMae S. in the Sharlene were

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

AMPALAYA (Momordica charantia) 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 Mae S. Palma, Sharlene movement No. 132

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

AMPALAYA (Momordica charantia) 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
Palma, Sharlene Mae S. No. 132 Class

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

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

Palma, Sharlene Mae S.

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BAWANG (Allium sativum)

Therapeutic effects: Antihypertensive, Anticholesterolemic, Antilipidemic,
Reduces platelet aggregation, Vasodilator, Expectorant, Antihistaminic, Antimicrobial
Palma, Sharlene Mae S. No. 132 Class

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BAWANG (Allium sativum) Medicinal plants for toothache relief (Marasigan, et. al 2000) The efficacy of crude ethanolic and aqueous extracts of guava, yerbabuena, avocado, bawang and calachuchi in inhibiting the growth of Lactobacillus acidophilus Antibacterial activity was determined by paper disc-agar plate method of Palma, Sharlene Mae S. assay No. 132

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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 Palma, Sharlene acids No. 132

Mae S.

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

BAYABAS (Psidium guajava)

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 Palma, Sharlene Mae S. actions No. 132

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

BAYABAS (Psidium guajava)

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) Sharlene Mae S. to compared Palma, No. 70% Green Cross distilled water and132

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

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
Palma, Sharlene Mae S. No. 132 Class

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

LAGUNDI (Vitex negundo)

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 Palma, Sharlene Mae S. No. 132 Class

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

LAGUNDI (Vitex negundo) 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)
Palma, Sharlene Mae S. No. 132 Class

HERBAL MEDICINE
Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

LAGUNDI (Vitex negundo)

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.
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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

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 acid (active

Balan, Ralph Class No. 03

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

NIYOG-NIYOGAN (Quisqualis indica L.)
Uses Adverse Effects

Antihelminthics diarrhea, abdominal pain, (ascariasis) and hiccups, distention alleviation of nephritis especially if the seeds are remedy for boils and eaten fresh or continuously ulcers for consecutivecaused relief from ache days by fever treatment of rheumatism
Balan, Ralph Class No. 03

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

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

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

SAMBONG (Blumea balsamifera)

Diuretic that helps in the excretion of urinary stones Anti-urolithiasis Hypertension Mild to moderate congestive heart failure
Balan, Ralph Class No. 03

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

SAMBONG (Blumea balsamifera)
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
Balan, Ralph Class No. 03

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

SAMBONG (Blumea balsamifera) Among the many herbal preparations being speculated as having antihypertensive properties, only “sambong” is undergoing a rigorous evaluation. At present, a randomized, doubleblind crossover study is ongoing to test the efficacy of this herbal medicine among mild hypertensiveness [reference unpublished].

Balan, Ralph Class No. 03

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

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 medicine
Balan, Ralph Class No. 03

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

TSAANG GUBAT (Ehretia microphylla Lam.)

antispasmodic for abdominal (stomach) pains high fluoride content – mouthwash; effective in treating intestinal motility Active compounds are triterpenes
Balan, Ralph Class No. 03

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

TSAANG GUBAT (Ehretia microphylla Lam.)

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

Balan, Ralph Class No. 03

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

TSAANG GUBAT (Ehretia microphylla Lam.)
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 Balan, Ralph Class No. 03

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

Ulasimang Bato /Pansit-pansitan (Peperomia pellucida)
“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
Balan, Ralph Class No. 03

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

Ulasimang Bato /Pansit-pansitan (Peperomia pellucida) 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 Balan, Ralph Class No. 03 pains and gout

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

Ulasimang Bato /Pansit-pansitan (Peperomia pellucida)
Uses

skin disorders (abscesses, pimples and boils) leaves and/or stalks boiled and pounded then applied directly to the afflicted area boil 1 cup of leaves/stem in 2 cups of water and taken twice a day
Balan, Ralph Class No. 03

Infusion or Decoction:

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

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

Balan, Ralph Class No. 03

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

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
Balan, Ralph Class No. 03

HERBAL MEDICINE
Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

HERBAL PLANT
Akapulko Ampalaya Bawang Bayabas Lagundi Niyog-niyogan Sambong Tsaang gubat Ulasimang-Bato Yerba Buena

CLINICAL USE
Antifungal NIDDM Antihyperlipidemic Antiseptic Asthma/Cough Antihelminthic Diuretic Antispasmodic Rheumatism/Gout Antiseptic/Antispasmodic
Balan, Ralph Class No. 03

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

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

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Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

Other Commonly Used Herbal Medicines in the Philippines Plant Uses
Banaba Luya/Ginger (Zingiber officinale) Sabila (Aloe barbardensis) Non-insulin dependent diabetes cold, cough, fever, sore throat, lowering cholesterol levels, nausea and vomiting; anti-fungal, antiviral, and anti-inflammatory properties moisturizing and hydrating the skin; supposed anti-oxidant effect when ingested (anti-hypertensive effects as well as for arthritis and diabetes) physical and cognitive improved performance, mood, and metabolism, Additive anticoagulant effect if used with Balan, Ralph Class No. 03 warfarin

Ginseng (Panax ginseng)

HERBAL MEDICINE
Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

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

Class

HERBAL MEDICINE
Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

Usual Formulations Available for Herbal Preparations For Oral Intake • Concentrated • Aromatic liquid of • Expression from • Elixirs Ground-powdered Dilute solutions solutions of sucrose preparation with fresh or dried fruits, flowering water-soluble • Capsules • high proportion of Sweet contained in herbsleaves for tops, vehicle herbal extracts alcohol, soft gel hard or glycerin nauseous herbal • Juices • Taken immediately Maceration for and propylene capsules medicines after extraction varying short • glycol swallowed, Easily • Higher sucrose (5 • Infusions • periods stored and Can be of or For potent time tasteless concentration for mins to 2 hours) refrigerated in • Syrups • nauseous herbal Very popular of preservation to • medicaments bottle tightly enclosed in Herbs sealed consumers herbal extracts cloth and suspended Maulion, Marienelle R. like a Class
No. 66

HERBAL MEDICINE
Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

Herbal Therapies

+

Prescription and Nonprescription 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 Medina, Kristianne Rachel P. harmful. Class No. 69

= possible dangerous side effects and/or reduced benefits from the medications

HERBAL MEDICINE
Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

Very little is known about herbdrug 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

Sources of information

Herbal products have not been regulated for purity and potency – anecdotal information – clinical experience – case reports
Class No. 69

– in vitro studies – observational studies – pharmacokinetic studies Medina, Kristianne Rachel P.

HERBAL MEDICINE
Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

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 Medina, Kristianne Rachel P. Class No. 69 evaluations

HERBAL MEDICINE
Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

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 Medina, Kristianne Rachel P.
Class No. 69

Education Act of 1994

HERBAL MEDICINE
Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

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 drug Medina, Kristianne Rachel P. therapy Class No. 69

HERBAL MEDICINE
Evaluation of Safety and Efficacy Herb-Drug and Herb-herb Interactions The 10 DOH Herbal Medicines

Potential Ha

Who is at risk of herb-drug interactions? Significant risk for patients Immunosuppressives cyclosporine Anticoagulants Warfarin Protease inhibitors (AIDS)

Medina, Kristianne Rachel P. Class No. 69

HERBAL MEDICINE
Evaluation of Safety and Efficacy Herb-Drug and Herb-herb Interactions The 10 DOH Herbal Medicines

Potential Ha

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, Medina, Kristianne Rachel P. Class and metabolic rate No. 69 dosage

HERBAL MEDICINE
Evaluation of Safety and Efficacy Herb-Drug and Herb-herb Interactions The 10 DOH Herbal Medicines

Potential Ha

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
Medina, Kristianne Rachel P. Class No. 69

HERBAL MEDICINE
Evaluation of Safety and Efficacy Herb-Drug and Herb-herb Interactions The 10 DOH Herbal Medicines

Potential Ha

Herb-Drug and Herb-Herb Decreased Interactionsbioavailability
of drug

Increased bioavailability of drug

↓ Absorption
fibers mucilage herbs ↑ pglycoprotein

↑ Absorption
Ginger Cayenne Black Pepper

↑ Metabolism
↑ CYP 450

↓ Metabolsim ↓ CYP 450
Grapefruit Juice

↑ Elimination
laxative herbs diuretic herbs
Class No. 69

↓ Elimination
Licorice- antidiuretic
Medina, Kristianne Rachel P.

HERBAL MEDICINE
Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

Herb-Drug and Herb-Herb 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 Medina, Kristianne Rachel P. Licorice and corticosteroids Class No. 69

HERBAL MEDICINE
Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

Herb-Drug and Herb-Herb Interactions Bromel ain

May ↑ bleeding with anticoagulants May ↑ effects of antibiotics ↑ efficacy of vincristine and 5fluoroiuracil

Medina, Kristianne Rachel P. Class No. 69

HERBAL MEDICINE
Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

Herb-Drug and Herb-Herb 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
Medina, Kristianne Rachel P. Class No. 69

HERBAL MEDICINE
Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

Herb-Drug and Herb-Herb 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
Medina, Kristianne Rachel P. Class No. 69

HERBAL MEDICINE
Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

Herb-Drug and Herb-Herb 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. Class the allicin may increaseNo. 69

HERBAL MEDICINE
Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

Herb-Drug and Herb-Herb 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

Medina, Kristianne Rachel P.

HERBAL MEDICINE
Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

Herb-Drug and Herb-Herb 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
Medina, Kristianne Rachel P. Class No. 69

HERBAL MEDICINE
Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

Herb-Drug and Herb-Herb 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
Medina, Kristianne Rachel P. Class No. 69

HERBAL MEDICINE
Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

Herb-Drug and Herb-Herb 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. Class No. platelets from clotting 69

HERBAL MEDICINE
Introduction History The 10 DOH Herbal Medicines Harmful Herb-Drug and Herb-herb Interactions Potential

Herb-Drug and Herb-Herb 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 thatNo. 69 drug or herb has Class no
Medina, Kristianne Rachel P.

HERBAL MEDICINE

Introduction Laws Collection, Processing and Manufacturing History The 10 DOH Herbal Medicines WHO Guidelines on GoodHarmfu Potential Agricu and Herb-herb Interactions Practices

Proclamation No.August 19, 2004, Pres. Gloria MacapagalOn 698
Arroyo declared the month of November as
Genetic factors

Intrinsic “TRADITIONAL &

Growth Characteristics

ALTERNATIVE HEALTH MONTH”

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 Practices Collection, Processing and Manufacturing

WHO Guidelines on Good Agricu

BA 2008BFAD 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
Lim, Vanessa

Class No. 2

HERBAL MEDICINE
Laws Practices Collection, Processing and Manufacturing

WHO Guidelines on Good Agricu

BA 2001BFAD 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 Lim, products Class No. 2 that are being claimed for the Vanessa

HERBAL MEDICINE
Laws Collection, Processing and Manufacturing Agricultural Collection Practices WHO Guidelines on Good

BA 2000BFAD Health Advisory on September 1, 2000 006

Warning on the use of “CUREALL” 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 "cureall" do not have any scientific basis of safety and efficacy Lim, Vanessa Class No. 2

HERBAL MEDICINE
Laws Collection, Processing and Manufacturing Agricultural Collection Practices WHO Guidelines on Good

ant Guidelines in Taking Herbal Medicine Factors Affecting Safety and Quality Control of Raw Materials

Intrinsic

Extrinsic
Environment Cultivation Harvest Post-harvest Processing Transport

Genetic factors Growth Characteristics

Collection methods

Storage practices
Macasaet, Aelleen P. No. 44 Class

HERBAL MEDICINE
Laws Practices Collection, Processing and Manufacturing

WHO Guidelines on Good Agricu

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
Macasaet, Aelleen P. No. 44 Class

HERBAL MEDICINE
Laws Practices Collection, Processing and Manufacturing

WHO Guidelines on Good Agricu

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
Macasaet, Aelleen P. No. 44 Class

HERBAL MEDICINE
Laws Practices Collection, Processing and Manufacturing

WHO Guidelines on Good Agricu

Sectio n2 Identification/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

Macasaet, Aelleen P. No. 44

Class

HERBAL MEDICINE
Laws Practices Collection, Processing and Manufacturing

WHO Guidelines on Good Agricu

Sectio n2 Identification/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 – Newly introduced plants
• Species/botanical variety used in traditional medicine of the original country
Macasaet, Aelleen P. No. 44 Class

HERBAL MEDICINE
Laws Practices Collection, Processing and Manufacturing

WHO Guidelines on Good Agricu

Sectio n2 Identification/authentication of cultivated medicinal plants

• Botanical Identity – Scientific name • Genus, Species, subspecies/variety, Author, Family – Local and English common names if available – Others (e.g. Cultivar) as appropriate
Macasaet, Aelleen P. No. 44 Class

HERBAL MEDICINE
Laws Practices Collection, Processing and Manufacturing

WHO Guidelines on Good Agricu

Sectio n2 Seeds and other propagation materials

• Specified • Provide information – Identity, Quality, Performance, Breeding history • Of best quality

Macasaet, Aelleen P. No. 44

Class

HERBAL MEDICINE
Laws Practices Collection, Processing and Manufacturing

WHO Guidelines on Good Agricu

Sectio n2 Cultivat 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
Macasaet, Aelleen P. No. 44 Class

HERBAL MEDICINE
Laws Practices Collection, Processing and Manufacturing

WHO Guidelines on Good Agricu

Sectio n2 Harv 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.
Macasaet, Aelleen P. No. 44 Class

HERBAL MEDICINE
Laws Practices Collection, Processing and Manufacturing

WHO Guidelines on Good Agricu

Sectio n2 Person nel

• Adequate knowledge • Maintain appropriate personal hygiene • Apply agrochemicals: wear appropriate protective clothing • Receive instruction on proper agricultural stewardship
Macasaet, Aelleen P. No. 44 Class

HERBAL MEDICINE

WHO General Strategies and Methods for Collection of Fresh Medicinal Plants Guidelines on Post Harvest Laws Collection, Processing and Manufacturing WHO WHO Good 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 Processing

WHO Post Harvest

ral Strategies and Methods for Collection of Fresh Medicinal Plan

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
Nallas, Anna Pauline R. Ecological Impact Class No. 91

HERBAL MEDICINE
WHO General Strategies and Methods for Collection of Fresh Medicinal Plants Processing

WHO Post Harvest

ral Strategies and Methods for Collection of Fresh Medicinal Plan

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
Nallas, Anna Pauline R. Class No. 91

HERBAL MEDICINE
WHO General Strategies and Methods for Collection of Fresh Medicinal Plants Processing

WHO Post Harvest

ral Strategies and Methods for Collection of Fresh Medicinal Plan

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
Nallas, Anna Pauline R. Class No. 91

HERBAL MEDICINE
WHO General Strategies and Methods for Collection of Fresh Medicinal Plants Processing

WHO Post Harvest

ral Strategies and Methods for Collection of Fresh Medicinal Plan

Person nel Experts Full documentation Botanical training Instructions  protection, sustainability, maintenance Knowledgeable links Welfare and safety Protect personnel  clothing and health

Nallas, Anna Pauline R. Class No. 91

HERBAL MEDICINE
WHO General Strategies and Methods for Collection of Fresh Medicinal Plants Processing

WHO Post Harvest

Post Harvesting

Inspection and sorting visual inspection for crosscontamination visual inspection for foreign matter Evaluation Appearance free from contamination and decomposition Storage and Transportation ensure their integrity
110

Ong, Maynard Ivan F.

Class No.

HERBAL MEDICINE
WHO General Strategies and Methods for Collection of Fresh Medicinal Plants Processing

WHO Post Harvest

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
Ong, Maynard Ivan F. 110

Class No.

HERBAL MEDICINE
WHO General Strategies and Methods for Collection of Fresh Medicinal Plants Processing

WHO Post Harvest

Processi ng

Indirect fire Drying ovens/rooms and solar dryers Baking Lyophilization Microwave or infrared devices

Ong, Maynard Ivan F. 110

Class No.

HERBAL MEDICINE
WHO General Strategies and Methods for Collection of Fresh Medicinal Plants Processing

WHO Post Harvest

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
Ong, Maynard Ivan F. 110 Class No.

HERBAL MEDICINE
WHO General Strategies and Methods for Collection of Fresh Medicinal Plants Processing

WHO Post Harvest

Specific Processing

boiling in water steaming soaking pickling distillation fumigation roasting natural fermentation treatment with lime and chopping
Ong, Maynard Ivan F. 110 Class No.

HERBAL MEDICINE
WHO General Strategies and Methods for Collection of Fresh Medicinal Plants Processing

WHO Post Harvest

Processing Facilities

Location – Accessibility – Drainage – Odors ,smoke, dust Building – Design and layout of station areas – Construction materials – Environment control
Ong, Maynard Ivan F. 110 Class No.

HERBAL MEDICINE
WHO General Strategies and Methods for Collection of Fresh Medicinal Plants Processing

WHO Post Harvest

Handling Areas

Construction considerations Preventing accumulation of dirt, moulds, and general cleanliness Objective Preventing contamination Preserving their therapeutic integrity Provide minimal alterations to Ong, Maynard Ivan F. their physical110 or chemical

Class No.

HERBAL MEDICINE
WHO General Strategies and Methods for Collection of Fresh Medicinal Plants Processing

WHO Post Harvest

Other Considerations

Water Supply Effluent and Waste Disposal Changing facilities and Toilets Hand-washing and disinfection facilities Lighting Ventilation Bulk packaging and Labeling
Ong, Maynard Ivan F. 110 Class No.

HERBAL MEDICINE
WHO General Strategies and Methods for Collection of Fresh Medicinal Plants Processing

WHO Post Harvest

Storage and Transportation Materials Identification Quality Assurance Documentation Personnel
Ong, Maynard Ivan F. 110 Class No.

HERBAL MEDICINE
WHO Generalof Safety and Efficacy Evaluation Strategies and Methods for Collection of Fresh Medicinal Plants Processing

WHO Post Harvest

ssification of Herbal Medicines World Health Organization (WHO)

• Guidelines for the regulation of herbal medicines in the SouthEast 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. No. 47 Class

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
Madulara, Glaiza M. No. 47

Class

HERBAL MEDICINE
Evaluation of Safety and Efficacy

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 Madulara, Glaiza M. Class

HERBAL MEDICINE
Evaluation of Safety and Efficacy

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
Madulara, Glaiza M. No. 47 Class

HERBAL MEDICINE
Evaluation of Safety and Efficacy Herb-Drug and Herb-herb Interactions The 10 DOH Herbal Medicines

Potential Ha

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
necessary for any pharmaceutical intended for human use

Acute toxicity studies

observe symptoms, herbal actions and toxicity after prolonged treatment
Madulara, Glaiza M. No. 47

Long term toxicity test

Class

HERBAL MEDICINE
Evaluation of Safety and Efficacy Herb-Drug and Herb-herb Interactions The 10 DOH Herbal Medicines

Potential Ha

Data Gathering Acute-Toxicity Testing

Animal species At least two species: rodents AND non-rodents Sex In at least one of the species, males and females should be used. Number of animals Rodents at least five animals per gender Non-rodents at least two animals per gender. Route of administration oral route - normal route of clinical administration parenteral route of administration
No. 47

Animal species At least two species: rodents AND non-rodents Sex Same number of male and female animals should be used Number of animals Rodents at least 10 males and 10 females Non-rodents at least 3 males and 3 females Route of administration oral route parenteral route of administration
Madulara, Glaiza M. Class

Long-term Toxicity Testing

HERBAL MEDICINE
Evaluation of Safety and Efficacy Herb-Drug and Herb-herb Interactions The 10 DOH Herbal Medicines

Potential Ha

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
Madulara, Glaiza M. No. 47 Class

HERBAL MEDICINE
Evaluation of Safety and Efficacy Herb-Drug and Herb-herb Interactions The 10 DOH Herbal Medicines

Potential Ha

Data Gathering Long-term Toxicity Testing
Administration period • test substance should be administered 7 days a week. • the commonly used ranges of administration periods 

Expected Period of Clinical Use Single Administration or Repeated Administration for < 1 week Repeated Administration, between 1 – 4 weeks Repeated Administration, between 1 – 6 months Long-term repeated administration for > 6 months

Administration period for the Toxicity Study

2 weeks – 1 month

4 weeks – 3 months

3 – 6 months

9 – 12 months

Madulara, Glaiza M. No. 47

Class

HERBAL MEDICINE
Evaluation of Safety and Efficacy

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 sideeffects 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
Madulara, Glaiza M. No. 47 Class

HERBAL MEDICINE
Evaluation of Safety and Efficacy

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

Madulara, Glaiza M. No. 47

Class

HERBAL MEDICINE
Evaluation of Safety and Efficacy

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 and Madulara, 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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