controle de qualidade de plantas medicinais do Brasil

TRADE AND QUALIT Y CONTRO L OF ME DICINAL PLANTS IN BRAZI L Review Arti cl e MARIA CRIS TIANE ARA NHA BRI TO 1* , JÉSSYCA WAN LUME DA SILVA GODINHO 1 , TÁLISON TAYLON DINIZ FERREIRA 1 , TÁSSIO RÔMULO SILVA ARAÚJO LUZ 2 , JOSÉ ANTO NIO COS TA LEITE 2 , DENISE FERNANDES COUT INHO MORA ES 3 , FLA VIA MARIA MENDONÇA DO AM ARAL 3 1 Gradua te Program in Health Sci ences, Biological and Health Sciences Ce nter, Federal University of M aranhão, CEP 6508 5 - 580 Sã o Luí s, MA, Brazi l , 2 Underg raduate Student, School of Pharmacy, Bi ologi cal and Hea lt h Sciences Center , Federal Univers ity of Mara nhão, 65085 - 580 São Luí s, MA, Brazil , 3 Received: 21 Ma y 2016 Revis ed and Accepted: 12 Aug 2016 Department of Phar macy, Bi olo gica l and Hea lth Sci ences Cen ter , Fed era l Un iver sity of Ma ranh ão, 65085 - 580S ão Luí s, MA, B razil Email: tiane9 1@ h otm ai l. co m ABSTR ACT The use of medic inal pl ants is in flu enced b y the cul tural leg acy of pop ular know ledg e of plan ts wi th thera peutic p urpos es, resu lting from th e ethni c mix of t he p opulati on, wi th a stron g Indi an, Eur opean , Afr i can , an d Asi an i nflu ence . O the r fac tors , su ch as diff icu lties in acce ss t he regu l ar h ea lth service s ass ociated with poor socio econo mic cond ition s, an d eas y acces s to m edicin al pl ants, and/o r her bal p roducts have cont ributed to cons olid ate he rbal med icine a s a w idely resourc e used b y the p opulat ion. H oweve r, thes e produ cts, de riv ed from p lants do not always poss ess the sufficien t safeg uards f or their u se and have not been pr oved f or thei r ther apeu tic s afety or qual ity. Thu s, i t emphas izes the need for stu die s on the market ing of med icinal pl ants, an d to evalua te the qu ality of th ese pro ducts in ord er to cond uct ph arma covigilan ce, en sure safe an d effec tive use , especi ally by con trib uting to the f ull devel opmen t of Phyto therap y. Keywo rd s: Herbal med icin es, Mar keting , Medi cin al pla nt s , Ph ar ma co vigi l a nce , Phytotherap y, Natu ral produ cts © 2016 Th e Autho rs. Pub lis hed by In novare A cademic Scie nces Pvt Ltd . Th is is an op en acc ess a rti cle und er t he CC BY lic e nse ( http:// creativecommon s. org/li censes/by/4. 0/ ) DOI: http :/ /dx. doi.or g/ 10.2 215 9/i jpps. 2 016v8i10. 12983 INTRO DUCT ION S ince the begin ning of civil izati on, man is depen den t on natur al re so urc e s, es peci al ly of plant orig in to heal , cure or p revent dise ase s [1] ; This pra ctice of usin g na tura l, fo lk a nd , herbal m edicin e or p hytoth erapy, is the a ccumu lation of kn owledge , passed on fro m one gene rati on to anoth er, th roug h the acti on of t he pla nts u sed in healin g and d iseas e pr eventi on. Each et hnic group has thei r knowledge about the thera peut ic va lue of pl ants , and this is pa rt of their cu ltur al backg round [ 5]. aim ing to preser ve and m aintai n this medical prac tice, th rough a handlin g rou te, adap tati on and modific ation of thes e resou rces f or their benef it. It c an b e said that the hab it of r esor ting to the h ealin g virtue s of cert ain pl ants is on e of the fir st man ifesta tions of man' s effor t to und er stand and u se natu re [2-4] . His torica lly, it is re cogni z ed th at this pract ice has been thro u gh sever al phas es of rep res entati on in society . It contr ib u te d to for m the thera peuti c ba sis a nd to be the first and/ or o nly th erap eutic resour ce used f or a large p art of the worl d's p opulati on. Mor eover, the usa ge of na tu ral prod uct s is also cons ide red the sid elin e for on ly use by th e les s benef ited s ocial class es with out a ccess to weste rn In the curren t scena rio, phytothe rap y has been inc lu de d in contemp orar y societ y, in both de velop ed and develop ing c ountr ies has become in tegr ated in to many soc ial classe s, henc e is not li mited to the peopl e living in rural a reas or regio ns lacking he alt h assistanc e [ 7]. tradit ional he alth serv ices [ 6, 4] . Accor ding to World He alth Org aniz ation ( WHO) , 70 - 90% of t he popul ati on in d ev elop ing c ountr ies r ely on her bal med icin e s especially fo r primary heal th care, and the s ignif ican t por tio n of the populat ion from d evel oped coun tries su ch as Can ada, F rance , Germany an d Italy als o relies on therapeut ic reso urces of plan ts an d thei r der iva tives [4]. Thi s is due to better compa tibil ity wit h the human body and les ser s ide e ffec ts a ssoci ated w ith th e use of pl ant - derived pr oducts. T his r eview aims to des cribe t he tr ade of medi cinal pl ants in Braz il, as well as di scuss es ways t o perf orm th e qualit y con trol of thes e produ cts in orde r to promote their saf e and effec tive use , and he nce would contribu te t o the d evel opme nt of p har macovig ilanc e in herb al medic ine. This wor k was ca rrie d out i n dat abas es (B iolo gica l Abst ract s, Chemi cal Abs trac ts, Medl ine, L i lacs , We b of Sc ience , Sci enc e Dir ect, PubMed ), as w ell as in th e offi cial comp endiu m and disser tati ons and the ses, c overing the la st thi rty y ears un til Ma rch 201 6. Th e keywor ds in combi nations use d in this revie w were se nso ry analys is, auth enticity , market ing, qu ality contr ol, pl ant d rug, pharma covig ilance, h erbal m edicine , health , herbal mark et, medicin al plan t, tra diti onal her bal med icine, p uri ty, p opular u se . Curre nt sce n a r i o: use and t rade o f medicinal plant s Look ing at th e in ternat ional scen ari o of pha r maceu ticals an d /or deriva tives of med icin al plan ts, th e sign ificant incr ease in sales of herbal m edicin es has been n oticed in Eur ope and the U nited St ates . In th ese pla ces, ther e hav e been an ann ual g rowth [ 8] rates betwe en 10 - 20%, and co nsumption is esti mated of U $ 14 bill ion p er ye ar . Back to the analy ses of the dome sti c market f or he rbal med icines , studies in dica te th at th ere i s a sharp r ise in the con sump tion of pla nt - derived products . Although th ere is a hi gh biod iver sity of plant s wi th a med icinal pu rpose in Braz il, fe w herb al med icine ha s been de veloped from th e indi genous plant s, and i t is not easy to find manufa cturing phy tomed icine in dru g s to re s . So th at th e majo rit y of the Br azilian peopl e prefe r acqu irin g the m edicinal plan t in p opular and infor mal fa irs [9]. Severa l studies have in dicated the factors affecting the high con sump t ion of pl ant - derived p ro duct s suc h as the di ffic ulty of accessin g to h ealth servi ce o f peo ple fro m dev el opi ng c ount r ies an d also because of sweepi ng green wa ve that t akes peo ple to use natu ral products as both food and medicines all over the world includ ing devel oped countries. The othe r fa ctor that up lift s the u sag e of pl an ts with med icin al p urp ose i s the scie ntific approach bot h to produce phytome dicines as wel l as Internat ional Journal of Ph armacy and Phar maceutical Sciences ISSN - 0975 - 1491 Vol 8, Issue 10, 2016 Br ito et al . Int J Pharm Pharm Sci, Vol 8, Issue 10 , 32 - 39 33 sourc e s of acti ve compou nds to be used as drugs in pharmace utica l i nd ust r ies [ 10 - 12 ]. In Braz il, man y fa ctors are fa vor i ng the prese rva tio n of th e use of plants f or medi cinal purp oses and hence contrib utin g sign ific antl y to the increased de mand for her bal p r o d uc t s. Some of these fa ctor s include t he rich biod iversit y, the cu ltural knowl edge fr om peop le and the inequ ality in the d istribu tion of res ource s for h ealth, with a concent ration of special ized se rvi ces in urban areas, f avorin g a mini mal p orti on o f th e pop ul ation [2] . In this reg ard s, it is ti mely and ess ential to expan d th e th erap euti c offerin gs in Brazil, especi ally af ter th e creat ion of t he Unif ied H ealt h System (SUS) with the aim of comp lianc e with its ba sic p rinc iples . T he adop tion of variou s measu res and regul ator y action s hav e been establ ished by the Fed eral Gove rnm ent to form alize th e herb al medicin e as an altern ative and/ or compl emen tary h ealth drug [ 8, 13, 14 ]. H erbal me dicine in Brazil As a regul ator y bench mark for s tructu ring and impl anta t ion of ph ytoth erapy in Br azil, Fe der al Gove rnm ent has taken step s an d initia tives , incl udin g th e Nation al P olicy on Medi cinal Pl ants an d Herbal M edicin es (P NPMF) an d the Na tion al Pol icy on Integ ra tive and Compl em entary Pr acti ces (P NPIC) on Uni fied Heal th Sy stem (SUS) , both p ublish ed in 2 006 [ 13, 15 ] . As the c onsequ ence of thes e lega l requ iremen ts, th e govern men t approved in 2008 the N ational Pr ogram f or Medicin al Plants an d Herbal Medicin es. Th is prog ram aims m ainly to the implemen t ati on of PNPMF and its goals such as th e enh ancem ent of th e produ ctiv e chain of medic inal pl ants and her bal med icines , encou raging resea rch and techn olog ical dev elop ment in this a rea, t rainin g of profe ssional s of th e herbal med icine s ect or and in clude h erbal produ cts on SUS with safety and quality [16] . Another adv ance ment in this area w as the p ublicat ion of the Ordinance 886, of April 20 th Regardin g th e mandat ory registr atio n of industr ial ized h erba l medicin e in the Braz ilian Reg ulat ory A gen cy ( AN VI S A) , t his pro cess start ed in 1 996 w ith th e firs t leg islati on req uirin g sc ientif ic s t udies to allo w the trad e of thes e pro ducts . Severa l upd ates of these standa rds h ave been publi shed over the y ears and curr ently the RDC 26 of May 13th, 2014 regu lates the regis trat ion and notifica tion o f manufa ctured herb al medi cines , whi ch are class ified as h erbal medicin es (MF) and tradition al herbal pr o ducts (P TF). T he d ifference between them is bas ed on the way to e ns ur e safet y and effi ca cy, whi ch is assess ed through cli nical trials or by the tradit ionalis m of use , respec tivel y [19]. , 2010 by M inistry of H ealth, which established the Live He rbal Pharm acies in the U nified H ealth System (SUS) [17 ]. This Ordinance was compl emented by RD C No. 18 of Ap ril 3rd, 201 3, that sets the techn ical regul ations f or good pra ctices of medicinal p lants and herbal produ cts in Live Herbal Phar macies [ 18] . This res olution is c omplemen ted b y the Normat ive Instru ction (I N) 02, of May 13th, 2014, which bring s the lists of plant specie s for the prepa ration of her bal med icines o r traditio n al herbal p rodu cts of simpl ified regi strat ion [ 19 ]. The con cepts rega rding t he ma in nom encla tures u sed in t his ar ea as a medicin al plan t, plant dru gs, h erbal med icine s and trad itional herbal p roduc ts are d escri bed in the men tioned legisl ation , esp ec ia ll y the RDC 26/2014 [ 20 ]. Plant drugs th at m ean th e dr y for m of the v ege table , medi cinal plan t or herbal med icine rep resen t altern atives to program s of Primar y Health Care to raise th e the rap eutic options . Mor eove r, thes e pro ducts are muc h cheap er to the popul atio n and also to govern ments that s uppor t thes e p rogram s . In Brazil, on e of these program s whe re the phyto therap y is quite u sed i s the Family Healt h Strateg y [ 12, 21 ]. Despi te ther e are man y regul ator y laws to organ ize th e pract ice of usage of med icin al plant s in Braz il, man y auth ors hav e identifi ed some pr oblems r ela ted to th e safe ty of thes e h erbal pro ducts trad ed in this cou ntry . It o ccurs due to t he un awaren ess and /or errone ous disclosu re of th e advan tage s of this pr actice and beco me wo rse when th ese h e rbal prod ucts h ave no standard ization nor quali ty contr ol. T he l ack of s cient ific st ud ies t o assur e the effe ctiven ess, saf et y , and qual ity of them is a si gni fi c a nt health p robl em [22, 23] . This situ ation is aggrav ated by t he tenden cy of a la rge pa rt of th e population ac qui ring products from plants in the informal mark et . It has also been docum ented that sell ers with no trad ition in the area , prov ing that this pr actic e is a re al risk of acqui ring and using an inappr opriat e materi al for con sumpti on, due to m isid entif icati on, erron eous ind icat ions of us e, inad equa te d osag e, us e of poor qua lity plants and toxic pla nts [ 8, 24]. Howev er, we mu st emp hasiz e that the ac quisi tion of p lants an d the ir deriva tives in pha rmac euti cal est ablishm ents is not entirel y saf e . R ecent n ation al stu dies ha ve pr oven tha t the ma rketin g at pharma cies an d drug store s, whi ch theo reti cally ha s the pe rform ance of te chni cally qual ified p rofe ss ional does no t guaran tee pro duct o ffering with good quality [2 5, 26 ]. These pr oblems exp ose the us er , as said bef ore, to a real risk of use of plants an d its deriva tives with poor quali ty . It coul d be s olve d if t here were a serious pr ocess of quali fi cation pharmaceut ical operation s in order to valida te analytical metho dologies for quali ty contr ol and st a ndardiz ation of th ese p roducts , and requir e the ex ercis e of authorities in monitoring , surveillan ce and quality contr ol of plan t species mark eted an d u sed f or thera peutic purp oses [ 2 7] . In this context, studi es c arrie d o ut by Si lveira e t al. sugges ted that for the dissemin ation of monit oring pr ograms and p harma cov igilance of medicinal p lants [ 2 8] as well as herbal medicines . Herbal o ft en cont a i ns a mixture of pl ants with fe w studie s on toxic ity and ad verse rea ctio ns . These resp onses can be either cau sed by the chemical constituen ts synthesiz ed by plant or adulteration , contaminati on, improper p reparation or and in approp riate, irra tional [ 29, 30 ]. In order to ensur e the safe and rational usag e of herbal medic ine as an alternative an d complemen tary option in t he therapeut ic , several problems shoul d be overcome . It inclu de s invest ment in her bal pharmaceuti cal research and de velopment , eff ective laws , a nd regulati ons that p romote respon sible market an d prod uction of botanical prod ucts. T he la ck of stu dies with nat ive plan t specie s in several cou ntries and o n standardization of botan icals and e valuation parameters of quality of med icinal p lants and their p roducts sho ul d also b e cons idered [ 22, 2 8, 31, 32] . Pharmacovi gilanc e in phytotherap y: quality control of medi cinal plant s and their d erived products According to M endes et al. pharmaco vigilan ce can be defin ed as th e scienc e relat ing to th e detec tio n, preven tion , evalua tion and preserv ation of ad verse effe cts or any oth er drug - relate d pr oblem s [33 ] . It aims to red uc e the morbidity an d mor talit y associ ated wi th drug use throu gh earl y det ection of sec urity p robl ems of th ese produ cts to patie nts and improv ing the sel ection an d rational use of medic ines by heal t h profe ssio na ls [ 34 ]. Thus, stu dies ai med to eva luat e t he qual ity of m edi cinal p lan ts and herba l me dicines has becom e one of the import an ce area o f resear ch [25] . Balbino and Dia s ha ve fo und that desp ite th e evid ence of th e inc reas ing rise o f mar keti ng pl an t s an d th eir de rivati ves , stu dies to evalua te th e certif icati on of s afe us e are stil l sca rce . The proper contr ol of mark et ing in the street or public mark ets and hea lt h f ood stor es is required t o be carr ied out [35]. This way , the ris e in the use of m edicin al plan ts and their der ived produ cts shoul d take p lace in a condu cive sett ing wi th the p rac tice of herb al med icine g roun ded in spec ific reg ulatory mand ates, based on the Ph arma covig ila nce objec tives, r equ iring [ 27] th e com mitm ent of govern ment s to th e imple men tation of str ict guid elin es. D espit e the rec ogniz ed imp ortan ce of sp ecific l egisl ation , only a bout 6 6 countr ies, in clud ing m ember s of th e WH O, ha ve so me leg islati on to thi s p ra ctic e [36 ] . Undenia bly, WH O recogn izes th e incre asing use of medi cinal plan ts and, con sequen tly, s timul ates p h ytoth erapy. E nsuring s afe, effec tive Br ito et al . Int J Pharm Pharm Sci, Vol 8, Issue 10 , 32 - 39 34 and ration al use of plants and their d erivati ves, as well as the qu ality contr ol cert ifi cati on is one of the biggest ch allen ges wor ld wi de . The conce rn abou t the qual ity of h erb al med icine s has b een shown to health auth oritie s and the p e o ple who u se th ese pr epar ations [ 37 ]. The use of any inp ut of p lant ori gin including wh ole plant, d rug or tradit ional / he rbal pr oducts and med icine s requir e certif icat ion of efficac y, safe ty , and quality of prod ucts av ailabl e for use . It ma y be provided by a set of measures su ch as the ful l exer cise of quali ty control , with targ eted eff ort s and res our ces to t he deve lopm ent , validat ion , and applicat ion of anal ytic al method ologie s [38 , 25] . The qualit y contr ol of raw mate rials to be used in nature an d/or as plant d rug in ext empor aneous p rep aration s or to be inse rted in the supp ly c hain to obta in t he her bal me dic ines shou ld be ba sed o n botani cal chem ical, phy sical and b iological analys e s to i nves tigate the au thent icity p ara meters, int egri ty , and pu rity [ 14, 12, 39 ]. During the last d ecad e , t he expan sion of d omest ic mark et of pl ant produ cts for m edicin al p urp os es ha s stim ulated stud ies, f ocu sing on the evalu ation of authen ticit y, integr i ty , and purity of raw mat erial s availa ble to th e popula tion. It' s worth emp has izing th at this i s the first wo rk condu ct ing a sy stem atic rev iew of qu alit y contr ol stud ies of plant s fo r med icinal u se in B razil . Mor ae s e t al. prov ided a rev iew about the auth ent icity of pl ants market ed worldw ide , us i ng molecul ar meth ods including DNA ba rco di ng and other mol ecu lar tech nique s [40]. The her bal medi cine t o be offe red as an altern ative to therape utic suppl ement sh ould b e foun ded on the a ssuran ce of qu ality , effec tivene ss , and ident ity of the me dicinal plant [28, 41 ]. Mat o s has reported th at t he be st way to maint ain the qualit y of medicin al plan ts an d thei r prepa ration s is t o ensu re a s tep o f oper ation s startin g fr om plan ting, harves ting, p rep rocessi ng to the final product [42 ]. Several t extboo ks are add ress ing these a spec ts , and it is bett er to emp hasi ze t he National Prog ram of Medicin al Plan t s an d Herb al Medic ines , and RD C 18/2014 guidelines establishing goo d manufa cturin g an d c ontrol p rac tices with in the Live Her bal Pha rmac ies of SUS [43 ]. The plan t mat erial t hrough all th ese op eration al step s will b e used as feeds tock , whic h require s the qu alifi ed exer cise of qu ality contr ol in all these stage s of the p r odu ction chai n of plan t in puts [36] . Definiti ons and metho dological op erations of quality control for me dicinal plants Standard s marketi ng An impor tan t gen eral a spect that d eterm ines the qu alit y of th e plan t material i s relat ed to m arket c onditi ons, esp eciall y for carr ying o ut trade in inap propr iate p lace s exp osing th e prod uct t o impr ope r cond ition s prone to con tam inati on like extreme c ondit i o ns o f t emper ature and h umidit y [25] . A poor mark eting c ondition of ps ych oa ctive he rbal dru gs in Diadema , S ão P aulo , Brazil ha s bee n reported b y Soare s Net o et al. and s tu dies by Amar al et al. have d emons tra ted t hat t h e s al e o f medicin al plant s in f ree m arke ts and fairs in the city of Sã o L uís , Mar a nh ão , Brazil compr omise the qua lity of pr oducts, emph as izing poor pack aging p lants, p oor hyg ien e of food h andlers , and gar bage and sewage cl ose to sal e locat ions [44 - 46 ]. Still on the top ic of the as sessm ent of market co ndit ion s, bein g co ntac ted th at mo st of the plan t materia l for med icin al pu rpose s does n ot foll ow th e curr ent reg ulati ons det ermin ation s as ev idence d by S oares a nd Mendonça [ 44 ]. Samplin g To perform th e quality control of natural p roducts , th e prime s tep is to star t with the sampl ing proce ss, which must repres ent the wh ole lot, to be exe rcised in a sp ecific l ocati on to av oid cros s conta minat ion, a nd in complian ce with the prov isions of literatu re [24,47 ] . Farias a nd Card oso rep or ted the samp ling prec autions th at s hould be taken in th e qu ality a ssess ment of pl ant inpu ts, min imizin g th e ris k of mis taken s ampl e taken . The ap propr iate sa mpling supp orts the real result s about the qu ality of plant materi als, avoid ing the wr ong quality cont rol rep ort, n ot th e chara cte ris tic of th e plant but th e analys is of a non - rep resen ta ti ve po rtion of th e whol e lot [48 , 24] . Sensor ial analysis Tradit ionally, textbo oks hav e pr esented p arame ters fo r asse ssing the quali ty of raw ma terial s inclu ding th e analy sis of visu al appearan ce, ta st e, odor and percep tion to the touc h ; and param ete rs may attes t aut h enticity (ident ity) a nd puri ty [48 ]. The monog raph s of herb al dru gs includ ed in the B razil ian Pharma copei a [47] define the sens ory ch aracte ristics as a para mete r for quality ass essm ent. I t can be c onsid ered that th e deter minati on of color , consi stency , taste or odor is similar t o the st anda rd sampl e establ ished in th e lit eratu re f or the drug in quest ion, an d it may b e indicat ive of the pl ant drug iden tificati on. Howe ver, it's nec essa ry to emphasiz e th at it cannot b e c onclusive . It is worth emph asizin g that s tandard sampl e is one th at is prev iously d es crib ed in off ic ial tex tbook s such as t he Braz ilia n Pharma copoe ia a nd ass ist in com pari son w ith matt er pro bl em, eith er pee l, leaf, and flowe r h eads [47 ]. Howev er, the an alys is of th ese sen sory chara cterist ics can prov ide good in dicato rs of qual ity, of the p lant mate rial su ch as sign s of deteri oration, ( fig. 1), the color ch a nge by f unga l con ta minat ion ( fig. 2), the color c hange of plant samp les d esi ccat ed indi catin g ina deq uate drying co nditio ns, and perce ption of in se c ts atta ck i n t he material s [48, 32 ]. Fig. 1: Sign s of det erioratio n of co mmercial s amples o f Peu mus boldus Molina (boldus) acq uired in pharmacies f rom São Luí s, Maranhão, Brazil Fig. 2: Color change in co mmerc ial samp les of V ernonia polyanthes Less ( enxuga ) sal e i n m arkets from São Luí s, Maranhão , Brazil, showing f ungal co ntaminat ion Br ito et al . Int J Pharm Pharm Sci, Vol 8, Issue 10 , 32 - 39 35 Authe nticity o f plant mater ial For ex ampl e , Plect ran thus b arb atus And rews is a pl ant speci e s wit h va lida tio n st udie s a nd i nclu ded at the National Li st of plants of SUS inter ests [50 ] . It can be easi ly adulterate d by Plec trant hus ne oc hi lus Schlt r an d Plec tra nt hus gr andis (Cr amer) R. Wi llemse . in Brazil Accor ding to Cardos o , auth ent icity can be def ined a s th e act of compa ring the botan ical id entity of the plant materi al to pr evio usly establ ished st andard s , lite rature, phar macopoe ial mon o graph an d phar macog nost ic a tlas [24 ]. The exch ange of pl ant sp ecies m ay o ccur a t var ious s tages of the produ ction chai n, and it can be acci dental or int ention al, fa vored by the si milar ity b etween pla n t spe cies and vern acular names [49] . A ll of them have morphol ogical similar ities , and th ey a re kno w n popularl y as bol d us , national bol do ( boldo nacion al ), gre at bo ldo (bo ld o grande), skunk boldo (boldo - gam bá), fake b oldo ( falso - bo l do ) a mong others [ 51 , 42 ] ( fig . 3). Fig. 3: Detai ls of leaves fro m Plectranthus barbatus An d r e ws ( f ake bold us ) , Plectra nthus neochilus Schl tr . ( bol d us ) a nd Plectranth us grandis (C ramer) R. Wil lems e ( great bold us ) Adulteration is considered a n intent io nal su bstit utio n of a for eig n plant , which incre ase s the weigh t and conseq uentl y the p rofit . It i s worth e mpha sizing th at the ad ulter ation by the s ubsti tution o f another organ of th e same p lant , diff erent f rom wh ere th e active ingred ient s are loc ated and occurred in an intent ional w ay is considered fraud [40]. It may resul t in l oss of secu rity b ecaus e it can lead t o severe p ois oning o r even deat h, due to the rep lace ment of medici nal s pecies by oth e r tox ic mat eri al [52 ]. Plant sp ecies Echinodorus grandiflorus a nd Echinodorus macrophyll u s , known as "ch apéu - de - cou ro , " are ind istinc tly used as anti - inflamm atory. Wid ely used with ther apeuti c purp ose, it has been constant ly suffe red thr ough th e pro ce ss o f adu ltera tio n, ma in ly wi t h flo ra l part s ind icating that t he spe cies w ere c ollect ed at th e time of f ruiting , or adu lte ration of the plac e whe re activ e ingred ien ts should b e located , the pre sence of plast ic mater ials, living and de ad ins ec t’s fr a gmen ts, ac c ord ing t o fi g. 4 [53 ]. Fig. 4: Ad ultera tion s on sampl es fro m Echinodorus grandiflorus (K unth) Micheli and Echinodorus macrophyllus (c hapé u - de - couro). I. Flowe r s; II. Plas tic m ate r i al s; III. Ins ects [53] Tobias et al. in their study of herb al medi cine s traded in d rug stor es of Maring á, P aran á, B razil reported the pr oblem s of authent icit y in herbal dru gs fro m spec ies wide spread u sed in Bra zi l , for exam ple, Mayten us ilicifolia ( esp inhei ra - santa ), guarana ( Paull i nia cupana Kunth ) a nd passion fruit ( Passifl o ra alata ) [54 ]. The authenticit y of plan t material has been evaluat ed by macros copic and microscop ic tests, based on compar ison with an authentic standard sampl e, descr iptions in P harmacop o eia s or literature . Micros copic ex amination [33 ] can be based on t he re searc h o f spec ific structures l ike epide rmal featur es (tricho m e s and st oma tas ), glandul ar elements, crys tals, vessel s, fibers, s tarch, am ong others. I t may be still he l d the histoch emi cal rea ctions [46] . The authen ticity can also be evaluated by th e p resenc e of ac tiv e c hemi cal con sti tu ents o f the species called chemical m arkers [45 , 5 5 , 24] . Studi es c onducted by Do nat o and Morrete s wi th Myrcia multiflora (Lam .) D C. (pe dra - u me - cá ) ( Myr tace ae fa mily ) and by Pad ilha et al. wi th Morus nigra L. (blac kbe rry , Moraceae f amily ) , emphas ize d the repres enta tion of macr o and m icrosc opic te sts on the verifi cation o f authen ticity of the se spec ies [ 56 , 57 ]. The morphol ogical an d anatom ical stu dies of m edicinal plants are es sent ial to supp ort th e evaluat ion proce ss of auth entic ity and are prov ided by seve ral studies [ 58 ]. Th e Brazili an Pharm acopo eia in its various ed ition s also rep resent s an impor tant s ource of comp arison f or qu ality evaluat ion. Milan eze - Gu tierr e e t al. i n their study fo r evalu ating the authe ntici ty of Plectranthus barbatus and Plectra nthus gra ndis sample s, demo ns tr at e d tha t the lea ves of b oth sp ecies are morp holog icall y simila r, making it dif ficult t o diff erenti ate by macros copic char ac teri sti c s . But the anato mic al analys is, quan tity of gl andula r and no n- glandular t richome s allow ed the dif ferenti ation of two species o f Plectr anthus bo th i n f resh s amples and dr ie d fragme nts [51 ]. It is necessary h ere to point o ut that th e phy toche mical profil e which allows us to ident ify th e presen ce of a g ro up o f su bsta n ces that may h elp in iden tify ing th e pl ant sampl e in a simp le, fas t an d eco nom ic al way [5 9 ]. Br ito et al . Int J Pharm Pharm Sci, Vol 8, Issue 10 , 32 - 39 36 The R DC 26/ 2014, the legi slation th at regul ates th e h erbal m edicin e regist rati on in Brazil, es tablish es th e marker concept as a "su bsta nce or class of su bstanc es ( e x: a lka loid s, fl avon oids , fatt y aci ds, e tc.) presen t in the raw mat erial wh ich is used a s a ref eren ce in q uali ty contr ol of raw plant material and herb al medi cine” . Accord ing to th is legisl ation, the marker preferab ly sho uld ha ve a correl ation with therap eutic e ffect . H owever , it also can be just an an alyt ical mark er, when i ts rela tionsh ip wi th the t herap eutic acti vity has not been proved so f ar [18] . Engel et al. evalua ted the au then ticit y of comme rc ia l samples of Bauhinia forficata L in k ( pat a de vac a). A dulter ation s in th e sam ples were f o und based on chromat og raphi c pro file s , iden tifyin g the flavon oid kae mpfer itrin, which is the analytic al chemical ma rke r for this sp ecies [60]. Mikania glom e ra t a Spr eng and Mikania laevigata Schultz Bip. ex Bak er a re speci es wid ely used by t he population for treat ment of respir atory d isease s and are common known as guac o [61 ]. B ot h of these sp ecies h ave morp h oan atom ical simil ariti es , and they are sol d w ithou t distin ction due t o limit ed dif ferenti ation b y macro and micr oscop ic te sts. Th ese sp ecie s hav e as th e che mical ma rker , coumarin (1,2 - ben zop yrone) ho w e v e r , it is also hard to dif fe re nti ate them b ased on th eir che mic al m ark er [62 ]. Boli na , Ga rc ia , and Du arte r epor ted the presen ce of coum arin , triterp enes, s teroid s and glyc osyl ated fl avon oids in both Mikania glome r at a Sp reng a nd Mikania laevigata Schul tz Bip. ex Baker , showin g sim ilar ch emi cal prof ile w hich i t is not appr opriat ed to the differ enti ation of th ose spe cies [63 ]. These st udi es are exa mples that ass essmen t of au thent icit y based o n the defini tion of the analytical ma rker is not alw ays effe ctive. T he presen ce of su bstanc es may be c ommon to several plant sp ecies , mainly f rom the sa me family or gener a . Therefore , i t cann ot be use d as a sole m ethod of id ent ificat ion [6 4]. In add ition to th e difficulty to eval uate the auth entic ity of pl a nt samples w ith simil ar mor p ho - anatom ical ch aracte ristics an d chemical ma rker s , the an alysi s may be impaired wh en the mate rial is f rag mented , mainl y powd ered . Usual ly , th is s ituat ion prev ails in the com merc ial izat ion, ma kin g the macro and mi crosc opic analy sis more difficult . Concerning c hem ica l testi ng , we mus t rem embe r that many edap hic - cl imatic f actors of plantin g and gath erin g place , and inade qua te cond ition s of dr ying o r stora ge can ca u se alte rati on of the chemica l com positio n thu s m aking it difficult to identify based on these t ests [64, 25, 40 ]. In real prosp ect of over com ing the dif ficult ies of th ose us ual method s for evalua ting t he auth ent icity, mole cular b iology h as be en used, wi th excel lent p ossi biliti es of suc cess, p roven by st udies in the area whic h have alread y been pu blished . Altho ugh i t is consi dered the mos t effi cient method to tes t the au then ticity of plan ts, it ha sn 't been de scribed in the qualit y contr ol eval uati on guide s of preparations with plants yet , published by WH O, n or in the law s of countr ies wh ere ther e's regul at ion of herbal medi cine or dietary suppl ements [40 ]. Onl y the Chi nese Ph armac opoe ia ( Phar maco poeia of the P eop le's R epubl ic of Chi na) pr esen ts mol ecula r bi o lo gy me th ods describ ed for p lant auth entic ity of an alysis us ed in tradit ion al Chine se med icine [6 5, 66 , 40 ]. Among th e me thods t o stud y the DNA f or p lant i den tificat ion, DNA Barco ding has been p roved to be th e most reliable m ethod to c he ck the authe nti city of raw plant ma teri al due to its accu rac y, sp eed, reprod ucibil ity , and r elativ e simp licity [33]. It wa s developed i n 2003 for the iden tifi cation of animals by using the mito cho ndri al COX1 g ene. L ater, this method was also u sed to iden tify high er plan t spe ci es. H ow ever , for thi s prop ose , it was nece ssary to ad d other genes an d in tergen ic reg ions of th e mito chond rial, nu clear or chloropl ast DN A as rbcL, ma tK, 18 S, 5.8S , ITS 1, I TS 2 , trnH - psb A, among o thers [ 67 - 70 ]. Studies by Mora es et al. show ed that altho ugh there is reliability in the identif ication and relative simplicity in its use , there are difficulties in this procedure, p rimarily related to the cost of these tech niques. Accordingly, mol ecular methods s hould only be employed when conv enti onal t ech niq ues are not effective in evaluating authenticity [40]. Pur ity of p lant m ate rial The qual ity contr ol is based on the evalu atio n of p uri ty , whi ch is related to detec ti o n of fo reign organic or inorg anic ele ments ( endogenous and exogeno us ), moist ure conten t, microb ial conta mina tion , paras itic , pe sticide r esid ues, h eavy metals [24 ] . Accor ding to RDC 26/2014, the pla n t raw material must prese nt purity rep ort, in cludin g fore ign matt er , wa ter conten t, total ashe s content , and ash insolubl e aci d . Thi s e v alu at io n al so in cludes the det ermi natio n o f heav y metal s , resid ues of pes ticide s radioa cti vity, when applic able, microb iolo gical cont amin ants and mycoto xins [20 ] . The toler anc e limits ar e express ed nu merically for a max imum an d minimu m value of each f oreign mate rial and ar e pr ese nted i n t he literatu re. It in dicat es the p urity of the plan t m aterial, and usu ally, it is expressed i n percen tage or absol ute term s [ 47, 36 ]. Accor di ng to the las t vers ion of Braz ilian P harmac opoe ia “p la nt drugs sho ul d b e free fro m fungi, inse ct s , bac teri a an d oth er conta mina tion ”. Unl ess otherw ise indica ted, th e perc entag e of foreign elem ents shoul d n ot exc eed 2% w/w [4 7]. The an alysis of fore ign elem ents can be perf orm ed macr osc opi call y (whole or grounded plant ) [ 24 ] . Ac cording t o the B razil i an Phar macop oeia , fore ig n matt ers are clas sifi ed i nto th ree ty pe s: (a) par ts o f th e plant from w hic h the dru g s are derived (b) an y part s or produ cts of other o rganism s than those sp ecif ied in th e defini tion and desc rip tion of th e drug in thei r respec tive m onograp h, and (c) other imp uri ties, m inerals or org anic , no n - related t o the drug [47]. A s tudy by Luc c a et al. about p urity e valuat ion of fif teen (1 5) commer cial sa mples of ch amomil e ( Cha mo milla recutita L. ) , t hat repres ents th e wide ly us ed d rug i n the p o pular prac tice in B razi l, showe d that altho u gh all sa mples were aut hentic , s ix (06 ) samp les had f orei gn ma tter c onten t above 5 % [71]. T hese ma teri als i nclud ed the l iving and dea d insect s; which can b e relat ed to th e crop and inappropriate post - harves t tran sport, as we ll as lack of qua lity control bef ore an d aft er th e packag ing op erati on. In this study, th ey also f ound o ther pa rts of the ch amomil e dif feren t than t he place where ac tive ing r edi ents ar e located ( f lo w e rs ) . ( f ig. 5) [24] . Fig. 5: The s trange mat erial in commercia l sampl es of dr y leaves f rom P eum us boldus Molin a (boldus) , acquir ed in popular market s in São Luís, Maranhão, Brazil L opes and Ne tto Ju nior stu died th e qual ity contr ol of comm erc ial samples of guar ana ( Pau llinia cupana Kunth ), fo und s trange material s presen t at a level abov e i ts thresho ld val u e ( 9.5 % ) , pro vi ng the po o r qualit y of the sa mples [72 ]. The exc essiv e pre sence of wate r in crude drugs allo ws th e act ion of enzyme s, whi ch can pr omot e chemi cal deg radat ion of th e consti tuen ts . In add itional , the high am ount of water can also pro mot e the growth of micro organ isms such as bacte ria and f ungi . Accor ding to t he Brazilian P harmac opoei a , the mo istur e conten t limit va ries fr om 8 % to 14% a ccord ing to th e spec ies and par t o f the plant [47]. Q uality a ssess ment stud y of he rbal drug s comme rcial ized in drugsto res of M aringá, P R, Braz il sh owed tha t among the nin ety - two Br ito et al . Int J Pharm Pharm Sci, Vol 8, Issue 10 , 32 - 39 37 ( 92 ) samples analyz ed, 1 5.4% w ere rejec ted be cause t hey p resent ed level s of th e conten t of total and acid i ns o lu b l e ashes that were above the p ermis sible l imit s [54 ]. The det ermin ation of th e ash es co ntent al low s verif icat ion of no n- volatil e inorgan ic imp uritie s, ind icating the pr esen ce of co n ta minant s such as soil or sand [ 48 ] . Ash con tent o utsid e th e standard s can als o repo rt pro b le ms in auth enti city as an ex chang e of plant sp ec ies or a mi xt ur e o f different species [37 ]. A study of Sc hwa nz addressed to the risk s and hazard s associ ated with th e pr esenc e of he avy m etal s in m edicin al plants s howe d t he warnin g that th e plan ts can e asil y absorb me tals p resent in th e environ ment . This contamin ation causes accumu latio n o f these elemen ts in p lant tis sues, r epres en ting the risks associate d wit h metals p hytot oxicity , and toxic ity to human and an imal h ealth [73]. Farias show ed that th e cont amina tion by he avy m etals in pha rmac eutic al prod ucts is relat ed to the pres enc e of lead, a rseni c, cadmiu m, cop per and mercu ry, as well as t he p res ence of pe sticid es. It is impor tant to emphas ize tha t pesti cides ar e ele ments whos e intak e should b e restri cted giv en th e pr oven t oxic ef fec ts [48]. Soares Net o et al. evalua ted the con tam inati on by p ath ogeni c microo rganism s in samples of p sychoac tive herbal drugs, acqu ired in th e popular trad ing of D iadem a, São P aul o, Brazil . The y found tha t 66.7% of samples did n o t conf orm to the qu ality sp ecifi cation s, being evidenc ed h eterotr oph ic bac teria , fung i , and/ or entero bact er ia ab ove the es tabli shed limit s [52]. The conta mina tion of pl ant produ cts thro ugh path ogen ic microo rgani sms sh ould be relate d to inad equ ate con diti ons o f harv e st and pos t - harves t pro cessi ng [74 ]. Accor ding to Mat os a nd Olivei ra and Ak isue, con tamin ation of herbal d rugs by f ungi, be sides repres enting ris k due t o the p rodu ction of t oxic s ubstan ces (myc otoxin s), ca n lea d to the des truc tio n and /or alterat ion of ac tive ingred ients, making them u nfit f or con sumpti on, rega rdle s s of the level of con tamin ati on [37, 55 , 59 ]. T he re sear ch of un desir abl e chemi cal c onst ituents in t he te st samp le can be used a s crite ria fo r pu rity evaluat i o n . Thus, the findin g of myc ot o xins, such as afl atoxin in plant sa mple show s poor qu ality o f the materi al, the same man ner as t he verifi cation of the presen ce of a substan ce of second ary met aboli sm that i s not synt hesi zed by the plant [48 ]. Integri ty of pl ant materia l The integri ty eval u ation is based on qual itativ e and quantita tive assays , being ind ispen sable in qu ality con trol. It is import ant to consid erate that plant raw mate rials may ex hib it vari ability i n chemic al composi tion, de pending on s everal i ntrins ic and e xt ri nsic [38] facto rs, influen cing th e con cen trati on of che mical consti tuen ts in plan t mater ial, and the refor e in th e ther apeuti c valu e of the he rbal produ cts [ 66 ]. Klein emp h as i ze d that botanica l may be as eff ec tive as m edicin es o btain ed from chemi cal synt hesis sin ce th e op eratio ns o f pl ant transf ormati ons in a medic ine prio ritize the preserv ation of the chemical in tegri ty of acti ve pr inci ple s, an d henc e, the phar macol ogi cal act ion of the plan t, en surin g the con stan cy of the desired biol o gi cal acti on [1] . As us ua l , a meth odo logy for the initial stud y of integ rity, Mat os establ ished the method olog y that can be used for s cree ning te st s or phytoch emic al scr een ing. These tests identif y th e clas ses o f seconda ry met abolite s by spe cific r eactions and ar e very h elpful due to its s pe e d, e fficie ncy , and low co st [9 , 59 ] . Howev er, th e phy toch emical screen ing is lim ited, s ince i t sign als just the pres ence of secon dary m etab olites cl asses . Thus , for the ident ificat ion of sp ecif ic m arker s , it is nec essa ry to do fur ther studies with is olati o n and struc tural elu cidation of the acti ve ingred ient s or su bstanc es resp on sible f or the biolog ical ac tion (active marker ), using chemi cal, phys ical meth ods or physi coch emic al in volvin g ch ara cter izat ion t echn iques , chromat ograp hic meth ods, ma ss spect rometr y, ultra vio let spectr oscopy , (visi ble and infrar ed) as wel l as pro ton and carb on nuclear mag neti c resonan ce (NMR ) [ 75 , 59, 38 ]. As ment ioned earli er, th e R DC 26/2014 which r egula tes th e regist ration and notific ation of ind ustri alized her bal , brings a defin i tion of m arker s ( analyti cal or ac tive ), previou sly na med chemical ma rker. It is necessa ry to emphas ize th at the d efini ng the analyti cal ma rker i s no t an easy task , cons idering th at when we speak o f the effectiv eness of plant drugs and deriva tives p roduct s we are refe rring to syn ergi stic action Phy t o - co m pl e x , not only isolat ed su bstan ce [20] . The official compend ia, par ticularl y in Brazil, as the Braz ilian Pharma copoeia d efin es the chro matog raphi c method s suc h as th in layer, l iquid high - resol ution and gas chro mato graph y. Hence, there are several studi es bas ed on chr omatog raphy , being directl y link ed to the qu ality c ontrol of co mmer cial samp les of herb al drug s and derived prep aration s wid ely us ed f or therap eutic purp oses [4 7]. We can ci te sam e studie s dev elo ped bas ed on r ese arch m arker s by chrom atog rap hic met hod s such as the p res ence of der ivati ves of o - hydroxy cinnamic a cid in Ech inodorus grandiflorus ( Cham and Schltdl. ); couma rin in s peci es Mikan ia glome ra t a S pre ng [61 ] and Mikania laevigata Sch. Bip. ex Bak e r; kaem pferit rin in B auh i nia forficata Li nk [60 ] ; aes ci nia fr om Aesculus hippoca stanum L [76 ] , and flavon oids in G inkgo bi loba L [27] . Accor ding to Miglia to e t al. standar dization studie s should priori tize the evalu ation of plant extracts through factoria l design, empha sizin g the defin ition of var iables th at influen ce the ex tracti on, since t his is a cru cial s tep in gett ing herbal substan ce , ensuri ng the separa tion s ubs tances of intere st from c omplex matrix [77]. CONCL USION The a bove l itera ture sh ows th e im p ortanc e of stu dies t o evalu ate th e quality of produ cts obt ained from plan ts that are commer cialized in the for mal an d inf ormal tr ade a cros s the B razili an ter ritory in ord er to guar ante e the secur ity of the po pulati on t h at use s thes e pro ducts. From th is re view cond uct ed on quality control plant raw m at eria ls, it i s poss ible t o obser ve qu alit y issue s, ma inly r egardin g th e authen ticity an d pur ity of m ater ials, em phas izing the poten tial probl ems of po isoni ng t hat can oc cur f rom th e con sump tion of pro ducts base d on pl ants with poor qual ity . ACKN O WLE DG EM EN T Authors would like to thank Resear ch Sup port F ounda tion of Ma ranhā o (FAPEM A), and CAPES for the financial support and techni cal suppo rt from the Federal Univer sity of Maran hão (UF MA). CONFLICT OF INTERESTS Declar ed none REFERE NCES 1. Klein T, Long hin i R, Brus chi ML , Mel lo JCP . 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