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Environ Monit Assess (2010) 164:369–377

DOI 10.1007/s10661-009-0899-4

Influence of Brazilian herbal regulations on the use
and conservation of native medicinal plants
Maria G. L. Brandão · Gustavo P. Cosenza ·
Acácia M. Stanislau · Geraldo W. Fernandes

Received: 21 September 2008 / Accepted: 13 March 2009 / Published online: 8 April 2009
© Springer Science + Business Media B.V. 2009

Abstract For decades, several native medicinal
species have been used by the pharmaceutical
industry in Brazil to create commercial products.
In 1995, the Ministry of Health, following the recommendations of the World Health Organization,
established herbal regulations (RDC 17) in order
to improve the quality of such products. In fact,
only plant species with conclusive results from
pharmacological and toxicological studies can be
used for creating medicines. In this study, we evaluated the consequences of RDC 17 on the use and
conservation of native medicinal plants by comparing the plant material used by six companies in
1995/1996 and 10 years later (2005/2006). Eightythree different species were used in 1995/1996, 50

of them native (60.2%), 16 exotic (19.3%), and 17
imported (20.5%). In 2005/2006, 44 species were
used by the companies and only 19 (43.2%) were
native. The category of plant material that saw the
largest decrease in use was roots, and in 2005/2006
leaves were more used. The study shows a strong
reduction in the collection of native species signalizing the importance of herbal regulations on
their conservation. It also points to the need for
pharmacological and toxicological studies of the
Brazilian native medicinal flora, as well as studies
on their ecology and conservation.

M. G. L. Brandão (B)
DATAPLAMT—Museu de História Natural e Jardim
Botânico, Universidade Federal de Minas Gerais,
31270-901 Belo Horizonte, Minas Gerais, Brazil
e-mail: mbrandao@ufmg.br

Introduction

M. G. L. Brandão · G. P. Cosenza · A. M. Stanislau
Laboratório de Farmacognosia,
Faculdade de Farmácia, Universidade Federal de
Minas Gerais, 31270-901 Belo Horizonte,
Minas Gerais, Brazil
G. W. Fernandes
Departamento de Ecologia Evolutiva &
Biodiversidade, Instituto de Ciências Biológicas,
Universidade Federal de Minas Gerais,
31270-901 Belo Horizonte, Minas Gerais, Brazil

Keywords Brazilian medicinal plants ·
Herbal regulation · Conservation

Owing to an astonishing mega-diversity, the
Brazilian flora represents one of the world’s richest sources of material for pharmacological use.
Historical records demonstrate that Amerindians
already used native species such as avocado
(Persea americana), wild potatoes (Ipomoea
batatas), mate (Ilex paraguaryensis), and cacao
(Theobroma cacao) thousand of years before the
invasion of the continent by Europeans (Wolters
1992). Despite the wide flora and current intellectual development, Latin American countries,
including Brazil, are involved in the international

and Comércio and Laboratório Magaraz. Rates 2001). 2005. taken from candeia wood (Eremanthus erythropappus (DC.” and species imported directly to extract the active principals were termed “imported species. alphabisabolol. Pilocarpine from the leaves of Jaborandi (Pilocarpus species.” those that have their origin in other parts of the world were termed “exotic species. These companies are represented by small laboratories that evaluate their products on the basis of traditional formulas (Ferreira 1998.anvisa. Laboratório Rodomonte.com. In the present study. Calixto 2000. Fernandes 2004). The negative perspective on conservation of native species in some places of Brazil highlights the urgent need to recover information on uses of native plant species and to promote studies on their ecology and conservation (Giulietti et al. including those found in areas of the Atlantic Forest and the Amazon where accelerated occupation takes place (Amorozo 2002. Ac- Environ Monit Assess (2010) 164:369–377 cording to these rules. or rutine. www. Shanley and Luz 2003.. 2008. a consequence of the high cost of industrialized medicine. However. located in the Southwest State of Minas Gerais. Shanley and Rosa 2005). and European) during the last several centuries has led to a progressive substitution from native medicinal plants to other species from elsewhere in Latin America (Dean 1996).merck. Copo Medicinal Indústria.” The numbers of species used during the two periods in each category are listed in Table 1. Michalski et al. Asteraceae). African. We studied the plants used by Indústria Farmacêutica Catedral. Some effort has been made by the companies to develop standardized phytomedicines from native species with proof of quality. established herbal regulations (RDC 17) in order to improve the quality of commercial herbal products. However. In 1995. a native species used in traditional medicine to treat inflammations (Calixto 2005). Laboratório Globo. After the identification of the botanical materials. very often. following the recommendations of World Health Organization. 1998). and efficacy. medicinal plants are widely used as home remedies by both rural and urban inhabitants of Brazil. obtained from favela fruits (Dimorphandra mollis Benth.370 pharmaceutical market only as suppliers of raw botanical material. For decades.) MacLeish. Fabaceae). Names of the species used. Acheflan® is produced with an essential oil obtained from Cordia verbenaceae. the species were divided into three different groups based on their distribution and use: species originally found in the Americas were termed “native species. Begossi et al. chinachemnet. 2004. Rutaceae). the Ministry of Health. the World Health Organization (WHO) recommendations for products for traditional use (WHO 1993. parts used in the preparation . RDC 17 (Brasil 1995). 2008). Materials and methods This study was performed through a comparison of the native medicinal plants used by six pharmaceutical companies of Minas Gerais in 1995/1996 and 10 years after the establishment of the first Brazilian herbal regulation. Di Stasi and Hiruma-Lima 2002. safety.br).com). several native medicinal species have been used by pharmaceutical companies in Brazil to create commercial products. Brandão et al. Data about the plants currently used in other parts of Brazil were verified on the website of the Brazilian Regulatory Agency. ANVISA (www. Currently. The accelerating destruction of Brazil’s botanically rich native ecosystems has also contributed to a gradual loss of knowledge about native plants used in traditional medicine. the complete acceptance of an herbal medicine by Brazilian governmental agencies can occur only after the efficacy and safety of the product has been scientifically determined (Carvalho et al. we present a list of Brazilian native medicinal plants used by certain pharmaceutical companies of Minas Gerais to make the traditional commercial formulas in 1995/1996 and 10 years after the publication of RDC 17 and discuss the influence of these herbal regulations on the use and conservation of native medicinal plants. Laboratório Belém Jardim. but only a few examples of success can be mentioned. 2002. are examples of natural compounds obtained from Brazilian native plants that are almost exclusively used by international pharmaceutical corporations (www.gov. the efficacy and safety of these products are not measured and they might not meet the minimal standard. the intense mixture of cultures (Native.

b.e Convolvulaceae Operculina macrocarpa L.) Meza Persea sp.d Fabaceae Bauhinia forficata Linkc Bowdichia virgilioides Kuntha.a. Plants used in 1995–1996 Data about the plants used in 1995/1996 as well as botanical material used in the preparation of the commercial products were furnished by the companies.b Vernonia polyanthes Less.b Anacardiaceae Anacardium occidentale L.) Müll.) Mart.b.exDCa.c Mikania glomerata Sprengela.Environ Monit Assess (2010) 164:369–377 371 Table 1 Number (%) of species used by the pharmaceutical companies in Minas Gerais in the two studied periods Origin 1995/1996 2005/2006 Native Exotic Imported Total 50 (60.3) 13 (29.c Plumeria lancifolia Müll.c Euphorbiaceae Phyllanthus niruri L.2) 12 (27. L.d.2) 16 (19. Argoviensisa Asteraceae Baccharis trimera (Less.b Tynnanthus fasciculatus (Vell. and the number of companies that have products prepared with that species are given in Table 2.St-Hil./Phyllanthus tenellus Roxb. botanical families.Arg.a Cucurbitaceae Cayaponia sp.) DCa.b. Mart.b Celastraceae Maytenus ilicifolia (Schrad.c Bignoniaceae Anemopaegma mirandum (Cham.d Hymenaea courbaril L.b.a.) DC.a.c Macrosiphonia velame (A.a.c Erythrina mulungu Martius ex Benth.d Lychnophora sp.e Mikania hirsutissima DC.c Apocynaceae Geissospermum laeve (Vell.b Jacaranda caroba (Vell. parts of the plant Table 2 Native medicinal plants and number of pharmaceutical companies which used them in 1995/1996 and 2005/2006 (n = 6) in Minas Gerais and in others parts of Brazil in 2008 (n = 22) Family/species Alismataceae Echinodorus macrophyllus (Kunth) Michelia.c.b.c.c Copaifera sp.c Senna occidentalis (L.a.) Linka.5) 44 (100) of the remedies.a.3) 17 (20.d.) Miersa.c Tabebuia avellanedae Lorentz ex Griseb.5) 83 (100) 19 (43. They provided the popular and scientific names.) Planch.c Lauraceae Ocotea sassafras (Meisn.a Popular names Parts Minas Gerais 1995/1996 2005/2006 Brazil Sep 2008 Chapéu de Couro Lvs 5 0 0 Cajueiro Bark 4 0 0 Pau Pereira Velame do campo Agoniada Bark Lvs Bark 5 5 5 0 0 0 0 0 1 Carqueja amarga Arnica da Serra Guaco Cipó Cabeludo Assa Peixe Wpl Aerial Lvs Lvs Lvs 4 3 3 5 3 4 0 5 0 0 0 0 8 0 0 Catuaba/Catuiba Caroba/Carobinha/ Ipê Roxo Cipó Cravo Rtz Lvs Bark Stm 5 5 4 5 3 3 0 0 0 0 0 0 Espinheira Santa Lvs 2 4 8 Jalapa do Brasil Rts 5 0 2 Taiuiá Rts 2 0 0 Quebra-Pedra Wpl 5 0 0 Pata de Vaca Sucupira Copaíba Mulungu Jatobá Fedegoso Lvs Sed Balsam Bark Fruits Rts 5 5 0 4 2 4 0 0 3 2 0 0 0 0 0 2 1 0 Canela Sassafrás Abacateiro Bark Lvs 2 6 0 3 0 1 .b.) Miersa. Table 3 shows the quantities of the different plant organs used in 1995/1996 and 10 years later.b. in 2005/2006.b.

d Remijia ferruginea (A.372 Environ Monit Assess (2010) 164:369–377 Table 2 (continued) Family/species Popular names Parts Minas Gerais 1995/1996 2005/2006 Lecythidaceae Cariniana brasiliensis Casarettoa Jequitibá Bark 3 0 Liliaceae Herreria salsaparilha Mart.a.a.c Quina Mineira Bark 4 4 Rudgea viburnoides (Cham.) Stokes.c Salsaparrilha Rts 5 0 Malvaceae Algodoeiro Lvs 5 0 Gossypium herbaceum L.) DC.e Guaraná Sed 5 5 Simaroubaceae Picrasma sp.b.) Miq. Pilocarpus microphyllus Jaborandi Lvs 6 5 Stapf ex Wardl.d.b Muirapuama Rts 5 0 Passifloraceae Passiflora sp.c Japecanga Rts 3 3 Solanaceae Solanum paniculatum L.St-Hil.a Limoeiro Bravo Lvs 2 0 Moraceae Brosimum gaudichaudii Tréculc Mamacadela Rts 5 0 Myrtaceae Stenocalyx pitanga O. Ipecacuanha Rts 6 1 Psychotria acuminata Benth.c.a. Berg Pitanga Lvs 3 0 Olacaceae Ptychopetalum olacoides Bent.a.)Miersa.d Barbatimão Bark 6 0 Monimiaceae Siparuna apiosyce (Mart.) Covillea.a.b.a.St-Hil) DC.c Menispermaceae Chondodendron platyphylla (A.c Douradinha Lvs 4 0 Violaceae Anchietea salutaris A.a.e Maracujá Lvs 6 5 Piperaceae Pothomorphe umbellata (L.b.) Benth.a. Congonha Lvs 5 0 Rutaceae Pilocarpus jaborandi Holmes.c. St-Hil.c Pariparoba/Caapeba Rts 5 2 Polygonaceae Polygonum hydropiperoides Michxc Erva de Bicho Rts 6 3 Rubiaceae Psychotria ipecacuanha (Brot.c.c Abútua Bark 5 2 Mimosaceae Anadenanthera colubrina (Vell.b.b.a. 2008a. b) d Species described in the Brazilian Official Pharmacopoeia fourth edition e Species included in RDC 48 (2004) Brazil Sep 2008 0 0 0 0 0 0 0 0 0 0 10 0 2 1 1 0 0 3 0 0 0 1 0 0 .a Quássia Bark 2 2 Simaruba sp.d Sapindaceae Paullinia cupana Kuntha.b.) Brenan Angico Lvs 6 0 Stryphnodendron adstringens (Mart.b Jurubeba Rts 6 4 Sterculiaceae Waltheria douradinha St-Hila. 2008) c Species mentioned by naturalists in Minas Gerais in the nineteenth century (Brandão et al. ex Tul.b.a.a.b.c Simaruba Bark 3 0 Smilacaceae Smilax japicanga Griseb.c Cipó Suma Rts 5 0 a Species described in the Brazilian Official Pharmacopoeia first edition b Species in products commercialized in pharmacies of Recife (Melo et al.

as shown in Table 1. Melo et al. 1991) as well as a chemical characterization (Wagner and Bladt 1996). The performed pharmaceutical analyses were very helpful for the identification of the plant material. or Picrasma were impossible to identify because their botanical and chemical profiles are very similar. roots. Results A total of 226 samples of botanical material were analyzed in 1995/1996 and 172 (76. and chemical descriptions of several medicinal species. macroscopic. However. The same trend was observed with the imported species that the number of species used decreased from . Oliveira et al. fruits. Plants used in 2005/2006 Data about the species used in this period were obtained directly from the companies or their websites. Langhammer 1989. Eschricher 1988. They are based on botanical (organoleptic.5%) imported species. Youngken 1943. as well as standard samples of the plants.br). 2007. There is no doubt of the importance of voucher herbarium samples for the correct identification of botanical materials. Golse 1955. Botanical characterization was complemented by a specific bibliography on the analysis of the herbal drug (Gilg et al. On the other hand. The six laboratories used 83 different plant species for preparing their commercial products.dataplamt.3%) exotic. leaves.2%) are native to Brazil. Fifty-four samples do not correspond to any descriptions or similarity in both the bibliography and standard samples and were excluded from the study. aerial parts of Baccharis trimera. Brandão 1996).3% in 1995/1996 to 27. and rhizomes in different forms (cut. Simaruba. Despite the reduction in the number of exotic species used in 2005/2006 (12 species) compared to 1995/1996 (16 species). 1942. and 17 (20.Environ Monit Assess (2010) 164:369–377 373 Table 3 Approximate quantities of different plant parts of native species used by the companies in 1995/1996 and 2005/2006 (×100 kg approximately) Parts Balsam Fruits Leaves Roots Seeds Whole plant Wood 1995/1996 0 5 51 67 5 5 39 2005/2006 3 0 26 16 5 4 12 used for preparation of products. it is possible to find detailed morphological. The number of species used in 2005/2006 was drastically reduced to 44 and only 19 (43. as well as the adulteration of the products. and microscopic) and chemical characterization (chromatographic methods. The botanical samples were composed of dried seeds. anatomical. 16 (19. the proportion increased from 19. However. and the name and address of each supplier. In DATAPLAMT. 50 of them (60. 2008). species of Passiflora. or pulverized).2%) native of America. The achieved results were also compared with standard plant species from a databank of herbal materials of the Federal University of Minas Gerais (DATAPLAMT). Deutschmann et al. Many samples such as pulverized seeds of Paullinia cupana. collecting usable herbarium samples in commerce or industry is very difficult since in almost all cases the vendors are not the collectors of the plants (Albuquerque et al. 1984. flowers. broken.org. the possibility of an inaccurate identification of the species must be considered since it can introduce bias in our work. Cayaponia. Species identification was complemented by a set of pharmaceutical analyses of identity used in the quality control of herbal drugs and recommended by Pharmacopoeias (FBRAS) and WHO (1998). Species identification was based only on the scientific names of the plants furnished by the companies or found on the internet since in 2005/2006 the correct identification of the plants was a requirement of ANVISA.1%) were identified by the botanical and chemical methods.3% in 2005/2006. Casamada 1977. These analyses were important because in 1995/1996 the correct identification of plant materials was not required of the companies and the substitution of plants for other species. was frequent. or leaves of Mikania hirsutissima were very easy to identify by the mentioned methods since they have their own morphological and chemical char- acteristics. which can be used to identify other samples (www.

200 kg. (Passifloraceae).700 kg. São Paulo = 9. 83 plant species. the companies used approximately 90 different species (Calixto 2000. 50 of them native (60. the use of wood fell by two thirds. most of these species were no longer used by the companies. seeing a reduction of 50% falling from approximately 5. being used by all six companies. In 2005/2006. we observed a strong reduction in the use of the native medicinal plants by the pharmaceutical companies since the establishment of RDC 17. In 1995/1996. Psychotria ipecacuanha (Brot.2%). In 2005/2006.) Coville (Mimosaceae). 19 of them native (43.) Miers. in all of Brazil. were used by the companies.) Brenan and S. (Rubiaceae). cupana Kunth) were still in use in 2005/2006. from approximately 3. Copaiba Balsam was the only native plant used in the production of new products. In 1995. (Rutaceae). The number of exotic and imported species used in 2005/2006 by companies in other parts of Brazil is also higher than the number of native species used. Persea sp. and Solanum paniculatum L. adstringens (Mart. 2008b) showing their long tradition of use as confirmed by the historical record. On the other hand. In 2005/2006. The most frequently used species in 1995/1996 were Anadenanthera colubrina (Vell.) Miq. (Lauraceae). products from six exotic and five imported species began to be made.600 kg in 2005/2006. The four suppliers of Minas Gerais were Environ Monit Assess (2010) 164:369–377 “raizeiros. . Amazonas = 1) supplied the plants in 1995/1996. while in 2005/2006 it was reduced to approximately one fourth of that (Table 3). This is a significant number since it was thought that. Paraná = 1.” people that collect wild plants commercialized for use directly by the companies. ex DC and Jacaranda caroba (Vell. Table 3 shows that 14 suppliers of different Brazilian states (Minas Gerais = 4. Discussion and conclusion The Traditional Medicine Division of WHO recognizes the therapeutic potential of traditional plant remedies and recommends that their efficacies be evaluated through pharmacological and toxicological studies (WHO 2002).) Stokes and P.900 to 1. It can be pointed out that this high number of species is a consequence of cultural and geographic aspects of Minas Gerais which is still rich in cultural aspects correlated with medicinal plants. scientific and popular names.) Coville (Mimosaceae) in their products. Rates 2001).2%).. There were 21 other species that were used by five companies in 1995/1996. (Solanaceae). Pilocarpus sp. fewer companies used these plants and none of them used A.) Brenan and Stryphnodendron adstringens (Mart. Bahia = 1.374 1995/1996 to 2005/2006 while the proportion increased (Table 1). Pothomorphe umbellata (L. Chondodendron platyphylla (A. The quantity of roots used in 1996 was approximately 6. In the same period. and parts used of 83 species and the number of companies that used these species during the two studied periods. Polygonum hydropiperoides Michx (Polygonaceae). 2008a). showing a strong reduction in the preparation of herbal medicines. Traditional formulas prepared with Brazilian native medicinal plants were widely used by local pharmaceutical companies in commercial products (Ferreira 1998. Table 2 shows the families.) DC. Passiflora sp. Fernandes 2004). In this study. acuminata Benth. Rio de Janeiro = 2.StHil. The quantity of leaves used has also suffered. Several organs of the plants were used both in 1995/1996 and 2005/2006. Twenty-eight others were also mentioned by European naturalists in the nineteenth century (Brandão et al. but from these only five (Anemopaegma mirandum (Cham. were used by certain pharmaceutical companies of Minas Gerais. Thirty-eight species used in 1995/1996 were described in the first edition of FBRAS as being important in conventional medicine (Brandão et al. only 44 plant species. 2006. in the 1990s. colubrina (Vell.100 kg in 1995/1996 to 2.. and P. The highest drop in use of plant organs in 1995/1996 was for roots (13 different species) while in 2005/2006 it was leaves (11 species). the Brazilian Health Ministry established herbal regulations (RDC 17) in order to improve the quality of such products (Brasil 1995).) Mart.

. It is clear that there is not enough knowledge. 2008a). M.) Stokes. cupana Kunth) are registered with the Regulatory Agency (ANVISA). Passiflora species. J. In fact. Ginkgo biloba.) Miq. Therefore. only nine have monographs in the fourth edition of FBRAS.) DC. and Zingiber officinalis. We argue that the native plant species already used by the national industry and that were listed in the first edition of Brazilian Pharmacopoeia must be submitted urgently to pharmacological and toxicological studies and reconsidered by the Brazilian Health Ministry.) DC. caroba (Vell. Remijia ferruginea (A.) DC. 23 were used by the companies of Minas Gerais in 1995/1996 but only five (Mikania glomerata Sprengel. The species Foeniculum vulgaris. 2008b). Species such as J. P. as shown in Table 2. trimera (Less. glomerata Sprengel.. despite being used by companies in 2005/2006.) Planch. Phyllanthus tenellus Roxb.. Panax ginseng. 2006. The influence of RDC 48 on the production of medicine with these plants can be clearly observed in Table 2.) Coville. and P. with proof of quality. cupana Kunth (Brasil 2004b). Pilocarpus jaborandi Holmes. caroba (Vell.P. were not used in 1995/1996 while in 2005/2006 the six companies have products made from them. both among the population and within the scientific community. mulungu Martius ex Benth. Some effort has been made by the companies towards the development of standardized phytomedicines with native species.) Planch. we suggest that a strong debate by the scientific public and policy makers should take place in an attempt to improve and facilitate the pharmacological study of the native flora. of the pharmacological properties of the Brazilian native plant species. which shows that several companies currently use these plants to prepare medicine.. Erythrina mulungu Martius ex Benth. S. If the trend for the use of exotic and imported species in the formulation of new medicines persists. Only four native species are recommended by RDC 48: Maytenus ilicifolia (Schrad. for example. hydropiperoides Michx. This situation points out the urgent necessity of ecological and conservation studies for these species since the bulk of plants traded in Brazil is harvested from wild populations which results in numerous local extinctions. published in 1929. One trend observed in our study is a clear substitution from the use of native species to exotic and imported species. Passiflora sp.. Matricharia recutita. Pilocarpus microphyllus Stapf ex Wardl. safety. will soon be removed from the market because they do not have enough results to demonstrate their efficacy and safety and cannot be approved by ANVISA. a much wider and diverse use of medicinal herbs 375 should be encouraged with the immense richness of Brazilian flora. The recent use of these and 21 other exotic and imported species by Brazilian pharmaceutical companies is a consequence of recent herbal regulations (RDC 48) which recommend the preparation of medicine with the species because several studies confirms their efficacy and safety (Brasil 2004a). adstringens (Mart. However. and efficacy. Aloe barbadensis.. (2008) used in pharmaceutical products sold in pharmacies of Recife. and P.E. M. From the listed species. acuminata Benth... Thirty-eight species used in 1995/1996 were described in the first edition of FBRAS.. M. published in 2004: B. The inclusion of a monograph for a species in the recent editions of FBRAS stimulates its use in the production of medicine. glomerata Sprengel. This fact highlights a disturbing situation. Hypericum perforatum. as they have long tradition of use confirmed by the historical record (Brandão et al. The same will happen to the 78 species recently listed by Melo et al. cupana .St-Hil) DC. ipecacuanha (Brot. Valeriana officinalis. cupana Kunth. Phyllanthus niruri L. or Smilax japicanga Griseb. umbellata (L. where foreign chemical pharmaceutical companies that produce medicines with species from their own country will be favored in the market while the national industry will be forced to start producing medicines with exotic or imported species.Environ Monit Assess (2010) 164:369–377 The traditional use of many species used in 1995/1996 was already described by European naturalists in the nineteenth century (Table 2) and they must be regarded as a priority for pharmacological studies. a city situated in northwest of Brazil. ilicifolia (Schrad. P. Melissa officinalis. P. Only P. showing their importance also in conventional medicine of the past (Brandão et al. we will lose traditional and scientific information on the pharmaceutical properties of many native species. for example.andP.

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