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PRESCRIÇÃO DE FITOTERÁPICOS 
COMO FAZER?
Prof. Leandro Medeiros 
(@prof_leandromedeiros)
Fortaleza, 2016
MAS AFINAL, QUE PRODUTOS SÃO 
CONTEMPLADOS PELA FITOTERAPIA?
CARACTERIZANDO A FITOTERAPIA
Vegetais
Metabólitos 
primários
Metabólitos 
secundários
(Nutrientes)
(Fitonutrientes ou fitoquímicos)
Alonso, 2004
low-density lipoprotein (LDL) in vitro in a concentration-
dependent manner.(10) Silybin appears to be the constituent of
silymarin responsible for the LDL antioxidant effect. In contrast,
silichristin and silydianin appeared to act as pro-oxidants, but
without significantly reducing the total LDL antioxidant capacity
of silymarin.
Free radicals are recognised as having an important role in
several pathological processes, including inflammation, necrosis,
fibrosis, atherosclerosis, carcinogenesis and ageing and in the
hepatotoxic mechanisms of various substances. The antioxidant
activity of silymarin is thought to contibute to its hepatoprotective
properties.(11, G55)
Hepatoprotective properties In vitro studies using isolated
hepatocytes have documented the protective activity of silymarin
and several of its components against cell damage induced by
various cytotoxic substances.(1)
In vivo studies in rats and mice have demonstrated the
hepatoprotective activity of silymarin and silybin in acute liver
toxicity induced by various toxic agents with different mechan-
isms of action, including carbon tetrachloride, galactosamine,
thioacetamide, ethanol, paracetamol (acetaminophen), thallium,
phalloidin and a-amanitin (the main toxic constituents of the
mushroom A. phalloides).(1) Experimental studies in chronic liver
toxicity induced by repeated administration of carbon tetrachlor-
ide, heavy metals, thioacetamide and several drugs, including
azathioprine and indometacin, have also demonstrated that
administration of silymarin and silybin protects against
damage.(1) Other studies have reported protective effects of
silymarin against liver injury induced by ischaemia(12) and gamma
irradiation.(13)
Studies in rabbits fed a high-fat diet for 12 weeks have shown
that histopathological alterations were least advanced in animals
which also received a silymarin–phospholipid complex.(14) In rats,
silymarin inhibited the development of diet-induced hypercholes-
terolaemia.(15) The hypocholesterolaemic effects of silymarin may
be due to the effects of silymarin on lipoprotein metabolism.(16)
The effects of silymarin on biliary bile salt secretion have been
seen in studies in rats.(17) Intraperitoneal silymarin (25, 50, 100
and 150mg/kg/day) for five days induced a dose-dependent
increase in bile flow and bile salt secretion. Stimulation of bile
salt secretion was mainly accounted for by an increase in the
biliary secretion of the hepatoprotective bile salts b-muricholate
and ursodeoxycholate.
Nephroprotective properties Silibinin injected into rats prior to
administration of cisplatin afforded protection of glomerular and
proximal tubular function.(18, 19) Silibinin does not affect the
cytotoxic activity of cisplatin.(19) Intraperitoneal silibinin (5mg/
kg) administered to rats 30 minutes before ciclosporin decreased
ciclosporin-induced lipid peroxidation but produced no protective
effect on the glomerular filtration rate.(20)
Anticancer activity Silybin at concentrations of 0.1–20 mmol/L
inhibited the growth of drug-resistant ovarian cancer cells and
doxorubicin-resistant breast cancer cells in vitro.(21) Furthermore,
silybin in the range of 0.1–1.0 mmol/L potentiated the effect of
cisplatin and doxorubicin in experimental tumour cell lines. When
applied to the skin of SENCAR mice, silymarin gave protection
against the effects of the tumour promoters 12-O-tetradecanoyl-
phorbol (TPA) and okaidic acid (OA).(22) Topical application of
silymarin prior to that of TPA and OA completely inhibited
induction of tumour necrosis factor a (TNFa) mRNA expression
in the epidermis. Substantial protection from photocarcinogenesis
in mice treated with phorbol ester or 7,12-dimethylbenz(a)
anthracene has been demonstrated.(23) The antitumour effect is
primarily at stage 1 tumour promotion and silymarin acts by
inhibiting cyclooxygenase 2 (COX-2) and interleukin 1a (IL-
1a).(24) Such effects may involve inhibition of promoter-induced
oedema, hyperplasia, the proliferation index and oxidant state.(25)
Treatment of serum-starved human prostate carcinoma DU145
cells with silymarin resulted in significant inhibition of transform-
ing growth factor a (TGFa)-mediated activation of the epidermal
growth factor receptor erbB1.(26) There was also a decrease in
tyrosine phosphorylation of an immediate downstream target, the
adapter protein SHC, together with a decrease in binding to
erbB1. In the silymarin-treated cell lines there was a significant
induction of the cyclin-dependent kinase inhibitors (CDKIs) Cip1/
p21 and Kip/p27 concomitant with a significant decrease in CDK4
expression, but no changes in the levels of CDK2 and CDK6 and
their associated cyclins E and D1, respectively. Additional
experiments showed that there was a significant inhibition of
constitutive tyrosine phosphorylation of both erbB1 and SHC, but
Figure 2 Milk thistle (Silybum marianum).
Figure 3 Milk thistle – dried drug substance (leaf).
Milk Thistle 431
MDosageDosages for oral administration (adults) for traditional uses
recommended in standard herbal reference texts are given below.
Fruit Crude drug 12–15 g daily in divided doses (equivalent to
silymarin 200–400mg daily).(G3)
Herb Approximately 1.5 g of finely chopped material as a tea, two
or three cups daily.
The doses of silymarin used in clinical trials have ranged from
280–800mg/day (equivalent to milk thistle extract 400–1140mg/
day standardised to contain 70% silibinin).(3) For hepatic
disorders, doses of up to 140mg (equivalent to 60mg silibinin)
two or three times daily have been suggested.(G43)
In Germany, the recommended regimen for treatment of
Amanita phalloides poisoning with a standardised silymarin
preparation (Legalon) is a total dose of silibinin (as the disodium
dihemisuccinate) (20mg/kg body weight) over 24 hours, divided
into four intravenous infusions each given over a 2-hour
period.(G43, G55)
Pharmacological Actions
Several pharmacological activities have been documented for milk
thistle fruit, including hepatoprotective, antioxidant, anti-inflam-
matory, antifibrotic and antitumour properties, as well as
inhibition of lipid peroxidation, stimulation of protein biosynth-
esis and acceleration of liver regeneration. Silymarin (an isomer
mixture comprising mainly silibinin, silichristin and silidianin) is
the pharmacologically active component of milk thistle fruit;
silibinin is the main component of silymarin. There is an extensive
literature on the pharmacological effects of silymarin and
silibinin, particularly with regard to their hepatoprotective
activity which provides supporting evidence for the clinical uses.
The pharmacology and clinical efficacy of milk thistle have been
reviewed.(1–3,G50, G55) The following represents a summary of
selected publications on this subject.
There is a lack of research investigating the pharmacological
effects of preparations of milk thistle leaf.(G2,G32,G35)
In vitro and animal studies
Antioxidant activity Silymarin and silibinin (silybin) are
antioxidants that react with free radicals (e.g. reactive oxygen
species) transforming them into more stable and less reactive
compounds.(1, 4–6) Silymarin and silybin have been reported to
inihibit lipid peroxidation induced by iron-linked systems in rat
liver microsomes(7, 8) and protect against phenylhydrazine-induced
lipid peroxidation in rat erythrocytes.(1) Furthermore, in rats,
intraperitoneal silymarin has been shown to increase total
glutathione in the liver, intestine and stomachand to improve
the reduced glutathione to oxidised glutathione ratio.(9) Silymarin
has been shown to inhibit copper-induced oxidation of human
Figure 1 Selected constituents of milk thistle.
430 Milk Thistle
M
Dosage
Dosages for oral administration (adults) for traditional uses
recommended in standard herbal reference texts are given below.
Fruit Crude drug 12–15 g daily in divided doses (equivalent to
silymarin 200–400mg daily).(G3)
Herb Approximately 1.5 g of finely chopped material as a tea, two
or three cups daily.
The doses of silymarin used in clinical trials have ranged from
280–800mg/day (equivalent to milk thistle extract 400–1140mg/
day standardised to contain 70% silibinin).(3) For hepatic
disorders, doses of up to 140mg (equivalent to 60mg silibinin)
two or three times daily have been suggested.(G43)
In Germany, the recommended regimen for treatment of
Amanita phalloides poisoning with a standardised silymarin
preparation (Legalon) is a total dose of silibinin (as the disodium
dihemisuccinate) (20mg/kg body weight) over 24 hours, divided
into four intravenous infusions each given over a 2-hour
period.(G43, G55)
Pharmacological Actions
Several pharmacological activities have been documented for milk
thistle fruit, including hepatoprotective, antioxidant, anti-inflam-
matory, antifibrotic and antitumour properties, as well as
inhibition of lipid peroxidation, stimulation of protein biosynth-
esis and acceleration of liver regeneration. Silymarin (an isomer
mixture comprising mainly silibinin, silichristin and silidianin) is
the pharmacologically active component of milk thistle fruit;
silibinin is the main component of silymarin. There is an extensive
literature on the pharmacological effects of silymarin and
silibinin, particularly with regard to their hepatoprotective
activity which provides supporting evidence for the clinical uses.
The pharmacology and clinical efficacy of milk thistle have been
reviewed.(1–3,G50, G55) The following represents a summary of
selected publications on this subject.
There is a lack of research investigating the pharmacological
effects of preparations of milk thistle leaf.(G2,G32,G35)
In vitro and animal studies
Antioxidant activity Silymarin and silibinin (silybin) are
antioxidants that react with free radicals (e.g. reactive oxygen
species) transforming them into more stable and less reactive
compounds.(1, 4–6) Silymarin and silybin have been reported to
inihibit lipid peroxidation induced by iron-linked systems in rat
liver microsomes(7, 8) and protect against phenylhydrazine-induced
lipid peroxidation in rat erythrocytes.(1) Furthermore, in rats,
intraperitoneal silymarin has been shown to increase total
glutathione in the liver, intestine and stomach and to improve
the reduced glutathione to oxidised glutathione ratio.(9) Silymarin
has been shown to inhibit copper-induced oxidation of human
Figure 1 Selected constituents of milk thistle.
430 Milk Thistle
M
Dosage
Dosages for oral administration (adults) for traditional uses
recommended in standard herbal reference texts are given below.
Fruit Crude drug 12–15 g daily in divided doses (equivalent to
silymarin 200–400mg daily).(G3)
Herb Approximately 1.5 g of finely chopped material as a tea, two
or three cups daily.
The doses of silymarin used in clinical trials have ranged from
280–800mg/day (equivalent to milk thistle extract 400–1140mg/
day standardised to contain 70% silibinin).(3) For hepatic
disorders, doses of up to 140mg (equivalent to 60mg silibinin)
two or three times daily have been suggested.(G43)
In Germany, the recommended regimen for treatment of
Amanita phalloides poisoning with a standardised silymarin
preparation (Legalon) is a total dose of silibinin (as the disodium
dihemisuccinate) (20mg/kg body weight) over 24 hours, divided
into four intravenous infusions each given over a 2-hour
period.(G43, G55)
Pharmacological Actions
Several pharmacological activities have been documented for milk
thistle fruit, including hepatoprotective, antioxidant, anti-inflam-
matory, antifibrotic and antitumour properties, as well as
inhibition of lipid peroxidation, stimulation of protein biosynth-
esis and acceleration of liver regeneration. Silymarin (an isomer
mixture comprising mainly silibinin, silichristin and silidianin) is
the pharmacologically active component of milk thistle fruit;
silibinin is the main component of silymarin. There is an extensive
literature on the pharmacological effects of silymarin and
silibinin, particularly with regard to their hepatoprotective
activity which provides supporting evidence for the clinical uses.
The pharmacology and clinical efficacy of milk thistle have been
reviewed.(1–3,G50, G55) The following represents a summary of
selected publications on this subject.
There is a lack of research investigating the pharmacological
effects of preparations of milk thistle leaf.(G2,G32,G35)
In vitro and animal studies
Antioxidant activity Silymarin and silibinin (silybin) are
antioxidants that react with free radicals (e.g. reactive oxygen
species) transforming them into more stable and less reactive
compounds.(1, 4–6) Silymarin and silybin have been reported to
inihibit lipid peroxidation induced by iron-linked systems in rat
liver microsomes(7, 8) and protect against phenylhydrazine-induced
lipid peroxidation in rat erythrocytes.(1) Furthermore, in rats,
intraperitoneal silymarin has been shown to increase total
glutathione in the liver, intestine and stomach and to improve
the reduced glutathione to oxidised glutathione ratio.(9) Silymarin
has been shown to inhibit copper-induced oxidation of human
Figure 1 Selected constituents of milk thistle.
430 Milk Thistle
M
Dosage
Dosages for oral administration (adults) for traditional uses
recommended in standard herbal reference texts are given below.
Fruit Crude drug 12–15 g daily in divided doses (equivalent to
silymarin 200–400mg daily).(G3)
Herb Approximately 1.5 g of finely chopped material as a tea, two
or three cups daily.
The doses of silymarin used in clinical trials have ranged from
280–800mg/day (equivalent to milk thistle extract 400–1140mg/
day standardised to contain 70% silibinin).(3) For hepatic
disorders, doses of up to 140mg (equivalent to 60mg silibinin)
two or three times daily have been suggested.(G43)
In Germany, the recommended regimen for treatment of
Amanita phalloides poisoning with a standardised silymarin
preparation (Legalon) is a total dose of silibinin (as the disodium
dihemisuccinate) (20mg/kg body weight) over 24 hours, divided
into four intravenous infusions each given over a 2-hour
period.(G43, G55)
Pharmacological Actions
Several pharmacological activities have been documented for milk
thistle fruit, including hepatoprotective, antioxidant, anti-inflam-
matory, antifibrotic and antitumour properties, as well as
inhibition of lipid peroxidation, stimulation of protein biosynth-
esis and acceleration of liver regeneration. Silymarin (an isomer
mixture comprising mainly silibinin, silichristin and silidianin) is
the pharmacologically active component of milk thistle fruit;
silibinin is the main component of silymarin. There is an extensive
literature on the pharmacological effects of silymarin and
silibinin, particularly with regard to their hepatoprotective
activity which provides supporting evidence for the clinical uses.
The pharmacology and clinical efficacy of milk thistle have been
reviewed.(1–3,G50, G55) The following represents a summary of
selected publications on this subject.
There is a lack of research investigating the pharmacological
effects of preparations of milk thistle leaf.(G2,G32,G35)
In vitro and animal studies
Antioxidant activity Silymarin and silibinin (silybin) are
antioxidants that react with free radicals (e.g. reactive oxygen
species)transforming them into more stable and less reactive
compounds.(1, 4–6) Silymarin and silybin have been reported to
inihibit lipid peroxidation induced by iron-linked systems in rat
liver microsomes(7, 8) and protect against phenylhydrazine-induced
lipid peroxidation in rat erythrocytes.(1) Furthermore, in rats,
intraperitoneal silymarin has been shown to increase total
glutathione in the liver, intestine and stomach and to improve
the reduced glutathione to oxidised glutathione ratio.(9) Silymarin
has been shown to inhibit copper-induced oxidation of human
Figure 1 Selected constituents of milk thistle.
430 Milk Thistle
M
Dosage
Dosages for oral administration (adults) for traditional uses
recommended in standard herbal reference texts are given below.
Fruit Crude drug 12–15 g daily in divided doses (equivalent to
silymarin 200–400mg daily).(G3)
Herb Approximately 1.5 g of finely chopped material as a tea, two
or three cups daily.
The doses of silymarin used in clinical trials have ranged from
280–800mg/day (equivalent to milk thistle extract 400–1140mg/
day standardised to contain 70% silibinin).(3) For hepatic
disorders, doses of up to 140mg (equivalent to 60mg silibinin)
two or three times daily have been suggested.(G43)
In Germany, the recommended regimen for treatment of
Amanita phalloides poisoning with a standardised silymarin
preparation (Legalon) is a total dose of silibinin (as the disodium
dihemisuccinate) (20mg/kg body weight) over 24 hours, divided
into four intravenous infusions each given over a 2-hour
period.(G43, G55)
Pharmacological Actions
Several pharmacological activities have been documented for milk
thistle fruit, including hepatoprotective, antioxidant, anti-inflam-
matory, antifibrotic and antitumour properties, as well as
inhibition of lipid peroxidation, stimulation of protein biosynth-
esis and acceleration of liver regeneration. Silymarin (an isomer
mixture comprising mainly silibinin, silichristin and silidianin) is
the pharmacologically active component of milk thistle fruit;
silibinin is the main component of silymarin. There is an extensive
literature on the pharmacological effects of silymarin and
silibinin, particularly with regard to their hepatoprotective
activity which provides supporting evidence for the clinical uses.
The pharmacology and clinical efficacy of milk thistle have been
reviewed.(1–3,G50, G55) The following represents a summary of
selected publications on this subject.
There is a lack of research investigating the pharmacological
effects of preparations of milk thistle leaf.(G2,G32,G35)
In vitro and animal studies
Antioxidant activity Silymarin and silibinin (silybin) are
antioxidants that react with free radicals (e.g. reactive oxygen
species) transforming them into more stable and less reactive
compounds.(1, 4–6) Silymarin and silybin have been reported to
inihibit lipid peroxidation induced by iron-linked systems in rat
liver microsomes(7, 8) and protect against phenylhydrazine-induced
lipid peroxidation in rat erythrocytes.(1) Furthermore, in rats,
intraperitoneal silymarin has been shown to increase total
glutathione in the liver, intestine and stomach and to improve
the reduced glutathione to oxidised glutathione ratio.(9) Silymarin
has been shown to inhibit copper-induced oxidation of human
Figure 1 Selected constituents of milk thistle.
430 Milk Thistle
M
Silybum marianum
Barnes, 2007
CARACTERIZANDO A FITOTERAPIA
3"
PLANTAS"MEDICINAIS"
(Lei"5991/1973)"
DROGAS"VEGETAIS"
DERIVADO(VEGETAL(
(EXTRATOS)(
FITOTERÁPICO(
MANIPULADO" INDUSTRIALIZADO(
MEDICAMENTO(
FITOTERÁPICO(
(REGISTRO"COMUM"
OU"SIMPLIFICADO)"
(RDC"26/2014)"
PRODUTO(
TRADICIONAL(
FITOTERÁPICO(
(REGISTRO"
SIMPLIFICADO"OU"
NOTIFICADO)"
(RDC"26/2014"e"
IN"02/2014)"
(
FARMÁCIAS(DE(
MANIPULACÃO(
(RDC"67/2007"/"
87/2008)"
FARMÁCIAS(
VIVAS((RDC"
18/2013)"
Uso"medicinal"
Chás"
alimenLcios"
(RDC(27/2010;(
RDC(219/2006;(
RDC(267/2005;(
RDC(277/2005(
Uso"não"medicinal"
Chás"
medicinais"
(RDC"26/2014)"
Uso"medicinal"
FITOTERAPIA
NUTRIÇÃO
FARMÁCIA
ENFERMAGEM
MEDICINA
FISIOTERAPIA
ODONTOLOGIA
BIOMEDICINA
RE CFN 525/2013 
RE CFN 556/2015
RE CFF 585/2013 
RE CFF 586/2015
RE COFEN 197/1997
RE COFFITO 380/2010
RE CFO 82/2008
RE CFBM 241/2014
CRITÉRIOS BÁSICOS PARA PRESCRIÇÃO (NUTRICIONISTAS)
• Estratégia complementar à prescrição dietética; 
• Exclusivamente por via oral; 
• Isento de prescrição médica; 
• Com indicações relacionadas à área de atuação do nutricionista; 
• Não associado com suplementos ou outras substâncias isoladas; 
• Fundamentadas em evidências científicas de eficácia e segurança ou 
por tradicionalidade de uso comprovada; 
• A PARTIR DE 2018: Prescrição de derivados de droga vegetal se dará 
somente com obtenção de título de especialista
RE CFN 525/2013; RE CFN 556/2015; RE CFN 334/2004
Medicamentos fitoterápicos 
Produtos tradicionais fitoterápicos 
Preparações magistrais fitoterápicas
Título de especialista em 
Nutrição em fitoterapia (Asbran)
CRITÉRIOS BÁSICOS PARA PRESCRIÇÃO POR NUTRICIONISTAS
RE CFN 525/2013; RE CFN 556/2015; RE CFN 334/2004
SELEÇÃO DE FITOTERÁPICOS PARA A PRÁTICA DA PRESCRIÇÃO
Relação de doenças
Relação de plantas 
medicinais/
fitoterápicos
Doença
X
Blumenthal, 1998
Planta medicinal/
fitoterápico
SELEÇÃO DE FITOTERÁPICOS PARA A PRÁTICA DA PRESCRIÇÃO
11 
 
Guia de orientação para registro de medicamento fitoterápico e registro e notificação de 
produto tradicional fitoterápico 
 
A RDC nº 26/2014 regulamenta o registro de Medicamentos Fitoterápicos (MF) e o registro 
e a notificação de Produtos Tradicionais Fitoterápicos (PTF). Essa norma também se aplica a 
produtos que sejam constituídos de fungos multicelulares e algas como Insumos Farmacêuticos 
Ativos (IFA), até que seja publicada regulamentação específica para essas classes. 
Este Guia e a norma de registro supracitada, quando tratam de fitoterápicos, referem-se 
tanto ao Medicamento Fitoterápico (MF) quanto ao Produto Tradicional Fitoterápico (PTF). A 
principal diferença entre essas duas classes é que o MF comprova sua segurança e eficácia por meio 
de estudos clínicos, enquanto o PTF comprova a segurança e efetividade pela demonstração do 
tempo de uso na literatura técnico-científica. Para serem disponibilizados ao consumo, tanto o MF 
quanto o PTF terão que apresentar requisitos semelhantes de qualidade, diferenciando-se nos 
requisitos de comprovação da segurança e eficácia/efetividade, bulas/folheto informativo, 
embalagens, restrição de uso e de Boas Práticas de Fabricação e Controle (BPFC) (Quadros 1 e 2). 
 
Quadro 1 - Diferenças entre os fitoterápicos tratados pela RDC nº 26/2014 
Diferenças Medicamento Fitoterápico 
(MF) 
Produto Tradicional Fitoterápico 
(PTF) 
Comprovação de Segurança e 
Eficácia/Efetividade (SE) 
Por estudos clínicos Por demonstração de tempo de uso 
Boas Práticas de Fabricação 
(BPF) 
Segue a RDC nº 17/2010 Segue a RDC nº 13/2013 
Informações do fitoterápico para 
o consumidor final 
Disponibilizadas na Bula Disponibilizadas no Folheto 
informativo 
Formas de obter a autorização 
de comercialização junto à 
Anvisa 
Registro ou 
Registro simplificado 
Registro, Registro simplificado ou 
Notificação 
 
 
Quadro 2- Semelhanças entre os fitoterápicos tratados pela RDC nº 26/2014 
 Medicamento Fitoterápico (MF) Produto Tradicional Fitoterápico (PTF) 
Semelhanças Requisitos de Controle de Qualidade (CQ) 
Controle do Insumo Farmacêutico Ativo Vegetal (IFAV) 
IN 04/2014, ANVISA
REFERÊNCIAS CONFIÁVEIS EM FITOTERAPIA
• Literatura reconhecida pela ANVISA (RDC 26/2014) 
• RDC 10/2010 (chás medicinais) 
• Natural Medicines Database(naturalmedicines.therapeuticresearch.com) 
• Examine Database (http://examine.com/)
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™� EgdYjXi�^c[dgbVi^dc�[gdb�dkZg�(%�Xdjcig^Zh�^cXajY^c\�6jhigVa^V!�<ZgbVcn!�J@�VcY�JH6#
Lg^iiZc�Wn�ZmeZgih�^c�i]Z�ÄZaYh�d[�e]VgbVXd\cdhn!�e]nidX]Zb^hign!�e]nide]VgbVXn!�Xa^c^XVa�]ZgWVa�
bZY^X^cZh!�e]nide]VgbVXdk^\^aVcXZ�VcY�gZ\jaVi^dc�d[�]ZgWVa�bZY^X^cVa�egdYjXih!�=ZgWVa�BZY^X^cZh�^h�Vc�
^ckVajVWaZ�gZ[ZgZcXZ�iZmi�[dg�e]VgbVX^hih�VcY�di]Zg�]ZVai]XVgZ�egd[Zhh^dcVah�l]d�gZfj^gZ�Zk^YZcXZ"WVhZY�
^c[dgbVi^dc�dc�]ZgWVa�bZY^X^cZh�jhZY�[dg�igZVibZci�VcY�egZkZci^dc�d[�]ZVai]�egdWaZbh#
;gdb�i]Z�gZk^Zlh�d[�egZk^djh�ZY^i^dch
»I]^h�\daYb^cZ�d[�Vji]Zci^X�\j^YVcXZ�XVccdi�WZ�[VjaiZY#¼� � ��� ���I]Z�>cYjhig^Va�E]VgbVX^hi
»°I]^h�^h�dcZ�d[�i]Z�WZhi�ZmVbeaZh�hd�[Vg�d[�V�jhZ[ja�\j^YZ�[dg�e]nh^X^Vch�VcY�Xa^c^XVa�]ZgWVa^hih°¼
I]Z�6bZg^XVc�=ZgW�6hhdX^Vi^dc
»>�i]dgdj\]an�gZXdbbZcY�i]^h�iZmi�[dg�VcndcZ�^ckdakZY�^c�i]Z�jhZ�d[�]ZgWVa�bZY^X^cZh!�eVgi^XjaVgan�e]VgbVX^hih�
VcY�di]Zg�]ZVai]�XVgZ�egd[Zhh^dcVah�^ckdakZY�^c�i]Z�jhZh�d[�]ZgWh�[dg�bZY^XVa�igZVibZcih#¼
8dbeaZbZciVgn�I]ZgVe^Zh�^c�Cjgh^c\�VcY�B^Yl^[Zgn
?dVccZ�7VgcZh�^h�6hhdX^ViZ�Egd[Zhhdg�^c�=ZgWVa�BZY^X^cZh!�HX]dda�d[�E]VgbVXn!�;VXjain�d[�BZY^XVa�VcY�=ZVai]�
HX^ZcXZh!�Jc^kZgh^in�d[�6jX`aVcY!�CZl�OZVaVcY0�A^cYV�6�6cYZghdc�^h�Eg^cX^eVa�E]VgbVXZji^XVa�6hhZhhdg!�
BZY^X^cZh���=ZVai]XVgZ�egdYjXih�GZ\jaVidgn�6\ZcXn!�AdcYdc!�J@0�?�9Vk^Y�E]^aa^ehdc�^h�:bZg^ijh�Egd[Zhhdg!�
8ZcigZ�[dg�E]VgbVXd\cdhn�VcY�E]nidi]ZgVen!�HX]dda�d[�E]VgbVXn!�Jc^kZgh^in�d[�AdcYdc!�J@
lll#e]VgbegZhh#Xdb
6ahd�VkV^aVWaZ�dca^cZ�
lll#bZY^X^cZhXdbeaZiZ#Xdb��
QUAL O REFERENCIAL TEÓRICO PARA A PRESCRIÇÃO DE FITOTERÁPICOS?
Evidências científicas Tradicionalidade de uso
Revisões sistemáticas com meta-análise de estudos 
clínicos ou monografias de bases de dados 
especializadas
Literatura oficialmente reconhecida 
(RDC 26/2014) 
 - Monografias da OMS 
 - Literatura secundária técnica 
 - Monografias de farmacopeias 
Estudos clínicos (randomizados, duplo-cegos, 
placebo-controlados) isolados
Revisões sistemáticas com meta-análise de estudos 
observacionais (coorte)
Estudos observacionais isolados
Séries ou relatos de casos
Opiniões de especialistas
FITOTERAPIA NA PRÁTICA CLÍNICA
Avaliação Prescrição Intervenção
Análise dos recursos 
terapêuticos disponíveis
Orientação 
de uso
Follow-up
• Risco x benefício 
• Custo x benefício
ReavaliaçãoÊxito 
terapêutico Objetivo 
alcançado
Objetivo 
não alcançado
Revisão da 
terapêutica
EXEMPLOS DE ESPÉCIES VEGETAIS 
DE INTERESSE TERAPÊUTICO
CAMELLIA SINENSIS
Composição bioativa
▪ Epigalocatequina Galato (EGCG) 
▪ Epicatequina Galato (ECG) 
▪ Epigalocatequina (EGC) 
▪ Epicatequina (EC) 
▪ Ácido gálico
Dosagem de catequinas 125 a 625 mg/dia
CAMELLIA SINENSIS
Med Chem Res (2012) 21:3347–3360
CAMELLIA SINENSIS
CAMELLIA SINENSIS
British Journal of Nutrition (2011), 106, 1297–1309 
CAMELLIA SINENSIS
British Journal of Nutrition (2011), 106, 1297–1309 
CAPSICUM ANNUUM
Composição bioativa Capsinoides 
▪ Capsiate 
▪ Di-hidrocapsiate 
▪ Nor-di-hidrocapsate
Dosagem de capsinoides 6 a 12 mg/dia
CAPSICUM	ANNUUM
CAPSICUM ANNUUM
Curr Opin Lipidol 2013, 24:71–77
Intervenção: 9 mg de capsinoides totais
Am J Clin Nutr 2012;95:845–50.
FIGURE 1. Mean (6SEM) DEE before (0 h) and after oral ingestion of 9 mg capsinoids (d) and placebo (s) in all subjects 
(A; n = 18), in BAT-positive subjects (B; n = 10), and in BAT-negative subjects (C; n = 8) and DEE during a 1-h period 
after ingestion of capsinoids (D; closed columns) and placebo (open columns), calculated as the AUC between 0 and 1 
h. ANOVA showed significant effects of time (P < 0.001), capsinoids x BAT (P = 0.03), and time x capsinoids · BAT (P = 
0.046) in B and C. aSignificantly different from 0 h, P < 0.05. bSignificantly different from placebo, P < 0.05. cSignificantly 
different from BAT-negative group given capsinoids, P < 0.05. BAT, brown adipose tissue; BAT+, BAT-positive; BAT–, 
BAT-negative; EE, energy expenditure; DEE, change in energy expenditure. 
GARCINIA CAMBOGIA
Composição bioativa ▪Ácido Hidroxicítrico (HCA) 
▪Cambogim 
▪Camboginol 
▪Bioflavonóides, xantonas, benzofenonas 
▪Antocianidinas
Dosagem de ácido hidroxicítrico 600 a 1.200 mg/dia
GARCINIA CAMBOGIA
Br J Nutr. 2009 Jun;101(12):1867-77
GARCINIA CAMBOGIA
J	Obesity	2011;	doi:10.1155/2011/509038
GARCINIA CAMBOGIA
J	Obesity	2011;	doi:10.1155/2011/509038
GARCINIA CAMBOGIA
J	Obesity	2011;	doi:10.1155/2011/509038
IRVINGIA GABONENSIS
Composição bioativa
Não disponível 
Erroneamente anunciado como mangiferina 
(Mangifera indica)
Dosagem do extrato IGOB131 (princípios ativos não declarados nos estudos). 150 mg x 1.050 mg
Lipids	in	Health	and	Disease	2009,	8:7-15
IRVINGIA GABONENSIS
Lipids	in	Health	and	Disease	2009,	8:7-15
IRVINGIA GABONENSIS
Lipids	in	Health	and	Disease	2009,	8:7-15
IRVINGIA GABONENSIS
The efficacy of Irvingia gabonensis supplementation in the management of overweight 
and obesity: a systematic review of randomized controlled trials. 
Onakpoya I, Davies L, Posadzki P, Ernst E. 
The aim of this systematic review was to evaluate the evidence from randomized controlled trials (RCTs) 
involving the use of the African Bush Mango, Irvingia gabonensis for body weight reduction in obese and 
overweight individuals. Electronic and nonelectronic searches were conducted to identify relevant RCTs. 
The bibliographies of located articles were also searched. No age, gender, or language restrictions were 
imposed. The reporting quality of identified RCTs was assessed using a methodological checklist adapted 
from the Consolidated Standard of Reporting Trials Statement and Preferred Reporting Items for 
Systematic Reviews and Meta-analyses guidelines. Two reviewers independently determined eligibility and 
assessed the reporting quality of included studies. Three RCTs were identified, and all were included. The 
RCTs all had flaws in the reporting of their methodology. All RCTs reported statistically significant 
reductions in body weight and waist circumference favoring I. gabonensis over placebo. The results from 
the RCTs also suggest positive effects of I. gabonensis supplementationon the blood lipid profile. Adverse 
events included headache and sleep difficulty. Due to the paucity and poor reporting quality of the RCTs, 
the effect of I. gabonensis on body weight and related parameters are unproven. Therefore, I. gabonensis 
cannot be recommended as a weight loss aid. Future research in this area should be more rigorous and 
better reported.
J Diet Suppl. 2013 Mar;10(1):29-38. 
IRVINGIA GABONENSIS
AMORPHOPHALLUS KONJAC (GLUCOMANAN)
Composição bioativa Polímeros de glicose e manose
Dosagem de fibras totais 500 a 4.000 mg/dia
• Promove aumento da saciedade (pela redução do esvaziamento 
gástrico, do trânsito intestinal), da excreção calórica pelas fezes, além 
de melhorar o perfil glicêmico e lipídico (reduz a biodisponibilidade de 
gorduras e açúcares provenientes da dieta) 
• Evidências científicas sugerem doses de 2 a 4g ao dia promovem 
redução de peso em indivíduos sobrepesados ou obesos e melhora o 
perfil glicêmico e lipidêmico, com baixa frequência de efeitos adversos, 
em adultos e crianças
Altern Ther Health Med; 2005; 11: 30–34 
Metab Clin Exper; 2007; 56: 1149–1158
AMORPHOPHALLUS KONJAC (GLUCOMANAN)
ALLIUM SATIVUM
Composição bioativa Óleos voláteis: compostos organossulfurados (alicina, aliina, alilpropil dissulfito, ajoeno, dialil dissulfido) 
Dosagem do 
marcador 3 a 5 mg de alicina
Food Use
Garlic is used extensively as a food and as an ingredient in foods.
It is listed by the Council of Europe as a natural source of food
flavouring (category N1). This category indicates that there are no
restrictions on the use of garlic in foods.(G16) Previously, garlic has
been listed as GRAS (Generally Recognised As Safe).(G41)
Herbal Use
Garlic is stated to possess diaphoretic, expectorant, antispasmo-
dic, antiseptic, bacteriostatic, antiviral, hypotensive and anthel-
mintic properties, and to be a promoter of leukocytosis.
Traditionally, it has been used to treat chronic bronchitis,
respiratory catarrh, recurrent colds, whooping cough, bronchitic
asthma, influenza and chronic bronchitis.(G2,G6,G32, G34,G49,G64)
Modern use of garlic and garlic preparations is focused on their
reputed antihypertensive, anti-atherogenic, antithrombotic, anti-
microbial, fibrinolytic, cancer preventive and lipid-lowering
effects.
Dosage
Dosages for oral administration (adults) for traditional uses
recommended in standard herbal and older pharmaceutical
reference texts are given below.
Dried bulb 2–4 g three times daily;(G6) fresh garlic 4 g daily.(G3)
Tincture 2–4mL (1 : 5 in 45% alcohol) three times daily.(G6)
Oil 0.03–0.12mL three times daily.(G6)
Juice of Garlic (BPC 1949) 2–4mL.(G11)
Syrup of Garlic (BPC 1949) 2–8mL.(G11)
Clinical trials assessing the effects of garlic powder tablets on
various parameters, including total serum cholesterol concentra-
tions, triglyceride concentrations, blood pressure, platelet aggre-
gation, vascular resistance, fibrinolysis and measures of peripheral
arterial occlusive disease, have generally involved the administra-
tion of doses of 600–900mg daily for 4–24 weeks.(G56) For
prophylaxis of atherosclerosis, ESCOP (European Scientific Co-
operative on Phytotherapy) states a dosage 0.5–1.0 g dried garlic
powder daily (approximately equivalent to alliin 6–10mg and
allicin 3–5mg).(G52)
Pharmacological Actions
In vitro and animal studies
Many pharmacological properties have been documented for
garlic and its constituents in vitro and in vivo (animals), including
antihypertensive, lipid-lowering, anti-atherogenic, antithrombo-
tic, fibrinolytic, antioxidant, anticarcinogenic, antitumorigenic,
immunomodulatory and antimicrobial activities. The pharmaco-
logical properties of garlic are attributed mainly to its sulfur-
containing compounds. An extensive review of the pharmacolo-
gical properties of garlic and its constituents is beyond the scope
of this monograph, although many studies are summarised below.
Figure 1 Selected constituents of garlic.
Figure 2 Garlic (Allium sativum).
Figure 3 Garlic – dried drug substance (bulb).
280 Garlic
G
Food Use
Garlic is used extensively as a food and as an ingredient in foods.
It is listed by the Council of Europe as a natural source of food
flavouring (category N1). This category indicates that there are no
restrictions on the use of garlic in foods.(G16) Previously, garlic has
been listed as GRAS (Generally Recognised As Safe).(G41)
Herbal Use
Garlic is stated to possess diaphoretic, expectorant, antispasmo-
dic, antiseptic, bacteriostatic, antiviral, hypotensive and anthel-
mintic properties, and to be a promoter of leukocytosis.
Traditionally, it has been used to treat chronic bronchitis,
respiratory catarrh, recurrent colds, whooping cough, bronchitic
asthma, influenza and chronic bronchitis.(G2,G6,G32, G34,G49,G64)
Modern use of garlic and garlic preparations is focused on their
reputed antihypertensive, anti-atherogenic, antithrombotic, anti-
microbial, fibrinolytic, cancer preventive and lipid-lowering
effects.
Dosage
Dosages for oral administration (adults) for traditional uses
recommended in standard herbal and older pharmaceutical
reference texts are given below.
Dried bulb 2–4 g three times daily;(G6) fresh garlic 4 g daily.(G3)
Tincture 2–4mL (1 : 5 in 45% alcohol) three times daily.(G6)
Oil 0.03–0.12mL three times daily.(G6)
Juice of Garlic (BPC 1949) 2–4mL.(G11)
Syrup of Garlic (BPC 1949) 2–8mL.(G11)
Clinical trials assessing the effects of garlic powder tablets on
various parameters, including total serum cholesterol concentra-
tions, triglyceride concentrations, blood pressure, platelet aggre-
gation, vascular resistance, fibrinolysis and measures of peripheral
arterial occlusive disease, have generally involved the administra-
tion of doses of 600–900mg daily for 4–24 weeks.(G56) For
prophylaxis of atherosclerosis, ESCOP (European Scientific Co-
operative on Phytotherapy) states a dosage 0.5–1.0 g dried garlic
powder daily (approximately equivalent to alliin 6–10mg and
allicin 3–5mg).(G52)
Pharmacological Actions
In vitro and animal studies
Many pharmacological properties have been documented for
garlic and its constituents in vitro and in vivo (animals), including
antihypertensive, lipid-lowering, anti-atherogenic, antithrombo-
tic, fibrinolytic, antioxidant, anticarcinogenic, antitumorigenic,
immunomodulatory and antimicrobial activities. The pharmaco-
logical properties of garlic are attributed mainly to its sulfur-
containing compounds. An extensive review of the pharmacolo-
gical properties of garlic and its constituents is beyond the scope
of this monograph, although many studies are summarised below.
Figure 1 Selected constituents of garlic.
Figure 2 Garlic (Allium sativum).
Figure 3 Garlic – dried drug substance (bulb).
280 Garlic
G
Food Use
Garlic is used extensively as a food and as an ingredient in foods.
It is listed by the Council of Europe as a natural source of food
flavouring (category N1). This category indicates that there are no
restrictions on the use of garlic in foods.(G16) Previously, garlic has
been listed as GRAS (Generally Recognised As Safe).(G41)
Herbal Use
Garlic is stated to possess diaphoretic, expectorant, antispasmo-
dic, antiseptic, bacteriostatic, antiviral, hypotensive and anthel-
mintic properties, and to be a promoter of leukocytosis.
Traditionally, it has been used to treat chronic bronchitis,
respiratory catarrh, recurrent colds, whooping cough, bronchitic
asthma, influenza and chronic bronchitis.(G2,G6,G32, G34,G49,G64)
Modern use of garlic and garlic preparations is focused on their
reputed antihypertensive, anti-atherogenic, antithrombotic, anti-
microbial, fibrinolytic, cancer preventive and lipid-lowering
effects.
Dosage
Dosages for oral administration (adults) for traditionaluses
recommended in standard herbal and older pharmaceutical
reference texts are given below.
Dried bulb 2–4 g three times daily;(G6) fresh garlic 4 g daily.(G3)
Tincture 2–4mL (1 : 5 in 45% alcohol) three times daily.(G6)
Oil 0.03–0.12mL three times daily.(G6)
Juice of Garlic (BPC 1949) 2–4mL.(G11)
Syrup of Garlic (BPC 1949) 2–8mL.(G11)
Clinical trials assessing the effects of garlic powder tablets on
various parameters, including total serum cholesterol concentra-
tions, triglyceride concentrations, blood pressure, platelet aggre-
gation, vascular resistance, fibrinolysis and measures of peripheral
arterial occlusive disease, have generally involved the administra-
tion of doses of 600–900mg daily for 4–24 weeks.(G56) For
prophylaxis of atherosclerosis, ESCOP (European Scientific Co-
operative on Phytotherapy) states a dosage 0.5–1.0 g dried garlic
powder daily (approximately equivalent to alliin 6–10mg and
allicin 3–5mg).(G52)
Pharmacological Actions
In vitro and animal studies
Many pharmacological properties have been documented for
garlic and its constituents in vitro and in vivo (animals), including
antihypertensive, lipid-lowering, anti-atherogenic, antithrombo-
tic, fibrinolytic, antioxidant, anticarcinogenic, antitumorigenic,
immunomodulatory and antimicrobial activities. The pharmaco-
logical properties of garlic are attributed mainly to its sulfur-
containing compounds. An extensive review of the pharmacolo-
gical properties of garlic and its constituents is beyond the scope
of this monograph, although many studies are summarised below.
Figure 1 Selected constituents of garlic.
Figure 2 Garlic (Allium sativum).
Figure 3 Garlic – dried drug substance (bulb).
280 Garlic
G
ALLIUM SATIVUM
• Uso tradicional reconhecido em doenças cardiovasculares: 
• Antihipercolesterolêmico 
• Anti-hipertensivo leve 
• Anticoagulante plaquetário 
• Tônico vascular
Barnes, 2007
Alho fresco 2-4g ao dia
Tintura (1:5, 45% de etanol) 2 a 4 mL , 3x ao dia 
Suco 2 a 4 mL ao dia
ALLIUM SATIVUM
CYNARA SCOLYMUS
Composição bioativa
Ácidos orgânicos: ácidos fenólicos, ácido clorogênico, ácido 
cafeico, cinarina. 
Flavonóides: Glicosídeos flavônicos (luteonina-7ß-rutinosídeo) 
Dosagem do 
marcador
24 a 48 mg de derivados de ácido cafeoilquínico 
expressos em ácido clorogênico 
final product.(G16) Previously, in the USA, artichoke leaves were
approved for use in alcoholic beverages only, with an average
maximum concentration of 0.0016% (16 ppm).(G41)
Herbal Use
Artichoke is stated to possess diuretic, choleretic, hypocholester-
olaemic, hypolipidaemic, and hepatostimulating properties.(7–9)
Modern use of artichoke is focused on its use in the treatment of
hyperlipidaemia, hyperlipoproteinaemia, non-ulcer dyspepsia and
conditions requiring an increase in choleresis. There is also
interest in the potential hepatoprotective properties of globe
artichoke, although this has not yet been tested in controlled
clinical trials.(10, 11)
Dosage
The German Commission E recommended an average daily dose
of 6 g drug, or an equivalent dose of extract (based on the herb-to-
extract ratio) or other preparations, for dyspeptic problems.(G3,
G56) A recommended dosage regimen for liquid extract (1 : 2) is 3–
8mL daily.(G50)
Dosages used in clinical trials of globe artichoke leaf extract
have assessed the effects of dosages of up to 1.92 g daily in divided
doses for up to six months.(12)
Pharmacological Actions
Several pharmacological properties have been documented for
artichoke leaf, including inhibition of cholesterol biosynthesis,
hypolipidaemic, antioxidant and hepatoprotective activity. It
remains unclear which of the constituents of artichoke are
responsible for its pharmacological activities. The dicaffeoylquinic
acids, which include cynarin, are likely to be an important group
of constituents in this respect.(11, G50) The sesquiterpene lactones,
such as cynaropicrin, and flavonoids, such as luteolin glycoside,
may also exert biological effects.(11)
In vitro and animal studies
Hypolipidaemic, hypocholesterolaemic and choleretic activity
Hypolipidaemic, hypocholesterolaemic and choleretic activities
are well documented for globe artichoke leaf extract and
particularly for the constituent cynarin.(10, 11) Globe artichoke
leaf extract not only increases choleresis and, therefore, choles-
terol elimination, but also has been shown to inhibit cholesterol
biosynthesis.(10) Preparations of globe artichoke leaf extract
inhibit cholesterol biosynthesis in a concentration-dependent
manner in studies in cultured rat hepatocytes.(13, 14) Low
concentrations (<0.1mg/mL) of globe artichoke extract achieved
around 20% inhibition, whereas 65% inhibition was noted with
concentrations of 1mg/mL. Luteolin was considered to be one of
the most important constituents for this effect, and it was
suggested that a possible mechanism of action might be indirect
inhibition of hydroxymethylglutaryl-CoA reductase (HMG-
CoA).(14) Other in vitro studies have documented a concentra-
tion-dependent inhibition of de novo cholesterol biosynthesis in
cultured rat and human hepatocytes for globe artichoke leaf
extract 0.03–0.1mg/mL.(15)
Several other experimental studies have documented lipid-
lowering effects for globe artichoke leaf extract and cynarin in
vivo.(10, 11) A study in rats explored the hypocholesterolaemic,
hypolipidaemic and choleretic effects of purified (containing 46%
caffeoylquinic acids, calculated as chlorogenic acid) and total
extracts of globe artichoke leaf (containing 19% caffeoylquinic
Figure 2 Artichoke (Cynara scolymus).
Figure 3 Artichoke.
Figure 4 Artichoke – dried drug substance (leaf).
68 Artichoke
A
final product.(G16) Previously, in the USA, artichoke leaves were
approved for use in alcoholic beverages only, with an average
maximum concentration of 0.0016% (16 ppm).(G41)
Herbal Use
Artichoke is stated to possess diuretic, choleretic, hypocholester-
olaemic, hypolipidaemic, and hepatostimulating properties.(7–9)
Modern use of artichoke is focused on its use in the treatment of
hyperlipidaemia, hyperlipoproteinaemia, non-ulcer dyspepsia and
conditions requiring an increase in choleresis. There is also
interest in the potential hepatoprotective properties of globe
artichoke, although this has not yet been tested in controlled
clinical trials.(10, 11)
Dosage
The German Commission E recommended an average daily dose
of 6 g drug, or an equivalent dose of extract (based on the herb-to-
extract ratio) or other preparations, for dyspeptic problems.(G3,
G56) A recommended dosage regimen for liquid extract (1 : 2) is 3–
8mL daily.(G50)
Dosages used in clinical trials of globe artichoke leaf extract
have assessed the effects of dosages of up to 1.92 g daily in divided
doses for up to six months.(12)
Pharmacological Actions
Several pharmacological properties have been documented for
artichoke leaf, including inhibition of cholesterol biosynthesis,
hypolipidaemic, antioxidant and hepatoprotective activity. It
remains unclear which of the constituents of artichoke are
responsible for its pharmacological activities. The dicaffeoylquinic
acids, which include cynarin, are likely to be an important group
of constituents in this respect.(11, G50) The sesquiterpene lactones,
such as cynaropicrin, and flavonoids, such as luteolin glycoside,
may also exert biological effects.(11)
In vitro and animal studies
Hypolipidaemic, hypocholesterolaemic and choleretic activity
Hypolipidaemic, hypocholesterolaemic and choleretic activities
are well documented for globe artichoke leaf extract and
particularly for the constituent cynarin.(10, 11) Globe artichoke
leaf extract not only increases choleresis and, therefore, choles-
terol elimination, but also has been shown to inhibit cholesterol
biosynthesis.(10)Preparations of globe artichoke leaf extract
inhibit cholesterol biosynthesis in a concentration-dependent
manner in studies in cultured rat hepatocytes.(13, 14) Low
concentrations (<0.1mg/mL) of globe artichoke extract achieved
around 20% inhibition, whereas 65% inhibition was noted with
concentrations of 1mg/mL. Luteolin was considered to be one of
the most important constituents for this effect, and it was
suggested that a possible mechanism of action might be indirect
inhibition of hydroxymethylglutaryl-CoA reductase (HMG-
CoA).(14) Other in vitro studies have documented a concentra-
tion-dependent inhibition of de novo cholesterol biosynthesis in
cultured rat and human hepatocytes for globe artichoke leaf
extract 0.03–0.1mg/mL.(15)
Several other experimental studies have documented lipid-
lowering effects for globe artichoke leaf extract and cynarin in
vivo.(10, 11) A study in rats explored the hypocholesterolaemic,
hypolipidaemic and choleretic effects of purified (containing 46%
caffeoylquinic acids, calculated as chlorogenic acid) and total
extracts of globe artichoke leaf (containing 19% caffeoylquinic
Figure 2 Artichoke (Cynara scolymus).
Figure 3 Artichoke.
Figure 4 Artichoke – dried drug substance (leaf).
68 Artichoke
A
Artichoke
Summary and Pharmaceutical Comment
Globe artichoke is characterised by the phenolic acid
constituents, in particular cynarin. Experimental studies (in
vitro and in vivo) support some of the reputed uses of
artichoke. Traditionally, the choleretic and cholesterol-
lowering activities of globe artichoke have been attributed to
cynarin. However, studies in animals and humans have
suggested that these effects may in fact be due to the
monocaffeoylquinic acids present in globe artichoke (e.g.
chlorogenic and neochlorogenic acids). Clinical trials
investigating the use of globe artichoke and cynarin in the
treatment of hyperlipidaemia generally report positive results.
However, further rigorous clinical trials are required to
establish the benefit of globe artichoke leaf extract as a lipid-
and cholesterol-lowering agent. Hepatoprotective and
hepatoregenerating activities have been documented for
cynarin in vitro and in animals (rats). However, these effects
have not yet been documented in clinical studies.
Species (Family)
Cynara scolymus L. (Asteraceae/Compositae)
Synonym(s)
Globe Artichoke.
Globe artichoke should not be confused with Jerusalem
artichoke, which is the tuber of Helianthus tuberosus L.
Part(s) Used
Leaf
Pharmacopoeial and Other Monographs
BHP 1996(G9)
BP 2007(G84)
Complete German Commission E(G3)
Martindale 35th edition(G85)
Ph Eur 2007(G81)
Legal Category (Licensed Products)
GSL(G37)
Constituents
The following is compiled from several sources, including
References 1 and 2, and General Reference G41.
Acids Phenolic, up to 2%. Caffeic acid, mono- and dicaffeoyl-
quinic acid derivatives, e.g. cynarin (1,5-di-O-caffeoylquinic acids)
and chlorogenic acid (mono derivative).
Flavonoids 0.1–1%. Flavone glycosides, e.g. luteolin-7b-rutino-
side (scolymoside), luteolin-7b-D-glucoside and luteolin-4b-D-
glucoside.
Volatile oils Sesquiterpenes b-selinene and caryophyllene
(major); also eugenol, phenylacetaldehyde, decanal, oct-1-en-3-
one, hex-1-en-3-one, and non-trans-2-enal.
Other constituents Phytosterols (taraxasterol and b-taraxa-
sterol), tannins, glycolic and glyceric acids, sugars, inulin, enzymes
including peroxidases,(3) cynaropicrin and other sesquiterpene
lactones, e.g. grosheimin, cynarotriol.(4, 5) The root and fully
developed fruits and flowers are devoid of cynaropicrin; highest
content reported in young leaves.(6)
Food Use
Artichoke is listed by the Council of Europe as a natural source of
food flavouring (category N2). This category indicates that
artichoke can be added to foodstuffs in small quantities, with a
possible limitation of an active principle (as yet unspecified) in the
Figure 1 Selected constituents of artichoke.
A
67
Artichoke
Summary and Pharmaceutical Comment
Globe artichoke is characterised by the phenolic acid
constituents, in particular cynarin. Experimental studies (in
vitro and in vivo) support some of the reputed uses of
artichoke. Traditionally, the choleretic and cholesterol-
lowering activities of globe artichoke have been attributed to
cynarin. However, studies in animals and humans have
suggested that these effects may in fact be due to the
monocaffeoylquinic acids present in globe artichoke (e.g.
chlorogenic and neochlorogenic acids). Clinical trials
investigating the use of globe artichoke and cynarin in the
treatment of hyperlipidaemia generally report positive results.
However, further rigorous clinical trials are required to
establish the benefit of globe artichoke leaf extract as a lipid-
and cholesterol-lowering agent. Hepatoprotective and
hepatoregenerating activities have been documented for
cynarin in vitro and in animals (rats). However, these effects
have not yet been documented in clinical studies.
Species (Family)
Cynara scolymus L. (Asteraceae/Compositae)
Synonym(s)
Globe Artichoke.
Globe artichoke should not be confused with Jerusalem
artichoke, which is the tuber of Helianthus tuberosus L.
Part(s) Used
Leaf
Pharmacopoeial and Other Monographs
BHP 1996(G9)
BP 2007(G84)
Complete German Commission E(G3)
Martindale 35th edition(G85)
Ph Eur 2007(G81)
Legal Category (Licensed Products)
GSL(G37)
Constituents
The following is compiled from several sources, including
References 1 and 2, and General Reference G41.
Acids Phenolic, up to 2%. Caffeic acid, mono- and dicaffeoyl-
quinic acid derivatives, e.g. cynarin (1,5-di-O-caffeoylquinic acids)
and chlorogenic acid (mono derivative).
Flavonoids 0.1–1%. Flavone glycosides, e.g. luteolin-7b-rutino-
side (scolymoside), luteolin-7b-D-glucoside and luteolin-4b-D-
glucoside.
Volatile oils Sesquiterpenes b-selinene and caryophyllene
(major); also eugenol, phenylacetaldehyde, decanal, oct-1-en-3-
one, hex-1-en-3-one, and non-trans-2-enal.
Other constituents Phytosterols (taraxasterol and b-taraxa-
sterol), tannins, glycolic and glyceric acids, sugars, inulin, enzymes
including peroxidases,(3) cynaropicrin and other sesquiterpene
lactones, e.g. grosheimin, cynarotriol.(4, 5) The root and fully
developed fruits and flowers are devoid of cynaropicrin; highest
content reported in young leaves.(6)
Food Use
Artichoke is listed by the Council of Europe as a natural source of
food flavouring (category N2). This category indicates that
artichoke can be added to foodstuffs in small quantities, with a
possible limitation of an active principle (as yet unspecified) in the
Figure 1 Selected constituents of artichoke.
A
67
CYNARA SCOLYMUS
• Uso tradicional reconhecido em: 
• Dispepsia funcional 
• Hipercolesterolemia leve a moderada 
• Evidências mostram benefícios na detoxificação hepática. 
Barnes, 2007
Extrato líquido (1:2) 3 a 8 mL ao dia
CYNARA SCOLYMUS
MODELOS DE 
PRESCRIÇÕES
Chás e extratos secos 
padronizados
Dr. Leandro Medeiros
Farmacêutico • CRF-PE: 3478
Para: (Nome do paciente)
Rx:
Allium sativum (alho) …. droga vegetal do bulbo
Modo de preparo:
• Cobrir o conteúdo de 1 colher de café rasa em 30 mL de água
• Deixar em temperatura ambiente por 1 hora
• Agitar ocasionalmente e coar
Tomar 1 cálice (30 mL), 2x/dia, antes das refeições, por 3 meses.
Não repetir receita.
Allium sativum (extrato seco, 5% de alicina) 50 mg
Camellia sinensis (extrato seco, 50% de polifenois 
totais)
250 mg
Aviar em cápsulas 120 doses
Dr. Leandro Medeiros
Farmacêutico • CRF-PE: 3478
Para: (Nome do paciente)
Rx:
Tomar 1 cápsula, 2x ao dia, após as refeições, por 3 meses.
Não repetir receita.
DÚVIDAS?
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E-mail: leandro.a.medeiros@gmail.com
Facebook: @leandro.a.medeiros
Obrigado!
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