Standardization Of Herbal Medicines - A Review
International Journal of Biodiversity and Conservation Vol. 4(3), pp. 101-112, March 2012Available online at http://www.academicjournals.org/IJBCDOI: 10.5897/IJBC11.163ISSN 2141-243X 2012 Academic JournalsReviewStandardization of herbal medicines - A reviewKunle, Oluyemisi Folashade1*, Egharevba, Henry Omoregie1 and Ahmadu, Peter Ochogu21Department of Medicinal Plant Research and Traditional Medicine, National Institute for Pharmaceutical Research andDevelopment (NIPRD), Idu Industrial Layout Idu, PMB 21 Garki, Abuja, Nigeria.2Tianjin University of Traditional Chinese Medicine, Tianjin, China.Accepted 12 January, 2012There is increasing awareness and general acceptability of the use of herbal drugs in today’s medicalpractice. Although, most of these applications are unorthodox, it is however a known fact that over 80%of the world population depends on herbal medicines and product for healthy living. This rise in the useof herbal product has also given rise to various forms of abuse and adulteration of the products leadingto consumers’ and manufacturers’ disappointment and in some instances fatal consequences. Thechallenge is innumerable and enormous, making the global herbal market unsafe. This review seeks toenlighten stakeholders in herbal medicine on the need to establish quality parameters for collection,handling, processing and production of herbal medicine as well as employ such parameters in ensuringthe safety of the global herbal market. The processes of good quality assurance and standardization ofherbal medicines and products were also discussed.Key words: Herbal medicine, standardization, quality control.INTRODUCTIONThe use of herbs as medicine is the oldest form ofhealthcare known to humanity and has been used in allcultures throughout history (Barnes et al., 2007). Earlyhumans recognized their dependence on nature for ahealthy life and since that time humanity has dependedon the diversity of plant resources for food, clothing,shelter, and medicine to cure myriads of ailments. Led byinstinct, taste, and experience, primitive men and womentreated illness by using plants, animal parts, and mineralsthat were not part of their usual diet. Primitive peoplelearned by trial and error to distinguish useful plants withbeneficial effects from those that were toxic or inactive,and also which combinations or processing methods hadto be used to gain consistent and optimal results. Even inancient cultures, tribal people methodically collectedinformation on herbs and developed well-defined herbalpharmacopeias. Physical evidence of the use of herbalremedies some sixty thousand years ago has been foundin a burial site of a Neanderthal man uncovered in 1960in a cave in northern Iraq (Solecki, 1975).Indeed, well into the twentieth century, much of thepharmacopeia of scientific medicine was derived from theherbal lore of native people. The knowledge of plantbased drugs developed gradually and was passed on,thus, laying the foundation for many systems of traditionalmedicine all over the world. In some communities herbalmedicine is still a central part of their medical system.Medicinal plants are widely distributed throughout theworld but most abundantly in tropical countries. It isestimated that about 25% of all modern medicines aredirectly or indirectly derived from higher plants (WHO,2005, 2002a,b, 1999a,b, 1998a,b, 1990, 1981, 1979; DeSmet, 1995; Duke and Martinez, 1994; Majno, 1975;Ackerknecht, 1973). Thus, herbal medicine has led to thediscovery of a number of new drugs, and non-drugsubstances.HERBAL MEDICINE*Corresponding author. E-mail: yemisikunle@yahoo.co.uk.An herb is a plant or part of a plant valued for itsmedicinal, aromatic, or savoury qualities. Herbs can be
102Int. J. Biodvers. Conserv.viewed as biosynthetic chemical laboratories, producing anumber of chemical compounds. Herbal remedies ormedicines consist of portions of plants or unpurified plantextracts containing several constituents, which often worktogether synergistically. Herbal medicine or herbalism isthe use of herbs or herbal products for their therapeuticor medicinal value. They may come from any part of theplant but are most commonly made from leaves, roots,bark seeds, and flowers. They are eaten, swallowed,drunk, inhaled, or applied topically to the skin Herbalproducts often contain a variety of naturally-occuringbiochemicals from plants, many of which contribute to theplant’s medicinal benefits. Chemicals known to havemedicinal benefits are referred to as “active ingredients”or “active principles” and their presence depends on anumber of factors including the plant species, the timeand season of harvest, the type of soil, the way the herbis prepared, etc.During the past decade, there has been increasingpublic interest and acceptance of natural therapies inboth developing and developed countries. Due to povertyand limited access to modern medicine, about 80% of theworld’s population, especially in the developing countriesuses herbal medicine as their source of primaryhealthcare (Bodeker et al, 2005; Mukherjee, 2002;Farnsworth et al., 1985; Bisset, 1994). In thesecommunities, traditional medical practice is often viewedas an integral part of their culture. In the West, people areattracted to herbal therapies for many reasons, the mostimportant reason being that, like our ancestors, it isbelieved they will help us live healthier lives. Herbalmedicines are often viewed as a balanced and moderateapproach to healing. Individuals who use them as homeremedies and over-the-counter drugs spend billions ofdollars on herbal products. As such, they represent asubstantial proportion of the global drug market (WHO,2005, 2002a, 1999a and b, 1990; Blumenthal, 2000;Blumenthal et al., 1998; Roberts and Tyler, 1997;Farnsworth et al., 1985).To achieve the desired benefit from herbalpreparations, an individual must take the required doseover a certain length of time. Although it is generallybelieved that most herbal preparations are safe forconsumption, some herbs like most biologically activesubstances could be toxic with undesirable side effects(Bisset, 1994).The variability of the constituents in herbs or herbalpreparations due to genetic, cultural and environmentalfactors has made the use of herbal medicines morechallenging than it would necessarily have been. Forinstance, the availability and quality of the raw materialsare frequently problematic, the active principles arediverse and may be unknown, and quality of differentbatches of preparation may be difficult to control andascertain. In most countries, herbal products arelaunched into the market without proper scientificevaluation, and without any mandatory safety andtoxicological studies. There is no effective machinery toregulate manufacturing practices and quality standards.Consumers can buy herbal products without aprescription and might not recognize the potentialhazards in an inferior product. A well-defined andconstant composition of the drug is therefore, one of themost important prerequisites for the production of aquality drug. Given the nature of products of plant origin,which are not usually constant and are dependent on andinfluenced by many factors, ensuring consistent quality ofproducts is vital for the survival and success of theindustry (Bauer, 1998).QUALITY CONTROL AND STANDARDIZATION OFHERBAL MEDICINES – CONCEPT AND SCOPEGenerally, all medicines, whether they are synthetic or ofplant origin, should fulfill the basic requirements of beingsafe and effective (EMEA, 2005; WHO, 2002c, 1998c,1996, 1991a,b, 1990, 1988). The term “herbal drugs”denotes plants or plant parts that have been convertedinto phytopharmaceuticals by means of simple processesinvolving harvesting, drying, and storage (EMEA, 1998).Hence they are capable of variation. This variability isalso caused by differences in growth, geographicallocation, and time of harvesting.Standardization of herbal medicines is the process ofprescribing a set of standards or inherent tativeandquantitative values that carry an assurance of quality,efficacy, safety and reproducibility. It is the process ofdeveloping and agreeing upon technical standards.Specific standards are worked out by experimentationand observations, which would lead to the process ofprescribing a set of characteristics exhibited by theparticular herbal medicine. Hence standardization is atool in the quality control process.Several problems not applicable to synthetic drugs ofteninfluence the quality of herbal drugs. For instance:1. Herbal drugs are usually mixtures of manyconstituents.2. The active principle(s) is (are), in most cases unknown.3. Selective analytical methods or reference compoundsmay not be available commercially.4. Plant materials are chemically and naturally variable.5. Chemo-varieties and chemo cultivars exist.6. The source and quality of the raw material are variable.The methods ofharvesting,drying,storage,transportation, and processing (for example, mode ofextraction and polarity of the extracting solvent, instabilityof constituents, etc.) also affect herbal quality.At present no official standards are available for herbalpreparations. Those manufacturers, who are currently
Kunle et al.doing some testing for their formulations, have their ownparameters, many of which are very preliminary in nature.Presently it is very difficult to identify the presences of allthe ingredients as claimed in a formulation. Hence thefirst important task is to evolve such parameter by whichthe presence of the entire ingredient can be tricmethods and evaluation of physicochemical propertiescan be tried to evolve pattern for identifying the presenceof different ingredient. Wherever possible these methodscan be applied for quantitative estimation of bioactivegroup of compounds like alkaloids, flavonoids,polyphenolic components or estimation of particularcompound (Wani, 2007)The need for standardization – Producers’ andconsumers’ perspectiveIn the global perspective, there is a shift towards the useof medicine of herbal origin, as the dangers and theshortcoming of modern medicine are getting moreapparent.It is the cardinal responsibility of the regulatoryauthorities to ensure that consumers get the medication,which guarantees purity, safety, potency and efficacy.The regulatory authorities rigidly follow various standardsof quality prescribed for raw materials and ufacturing operation through statutory imposed goodmanufacturing practices. These procedures logicallywould apply to all types of medication whether included inmodern system of medicine or one of the traditionalsystems.Though herbal products have become increasinglypopular throughout the world, one of the impediments inits acceptance is the lack of standard quality controlprofile. The quality of herbal medicine that is, the profileof the constituents in the final product has implications inefficacy and safety. However, due to the complex natureand inherent variability of the constituents of plant-baseddrugs, it is difficult to establish quality control parameterthough modern analytical technique are expected to helpin circumventing this problem. Furthermore, theconstituents responsible for the claimed therapeuticeffects are frequently unknown or only partly explained.This is further complicated by the use of combination ofherbal ingredients as being used in traditional practice. Itis common to have as many as five different herbalingredients in one product. Thus batch to batch variationstarts from the collection of raw material itself in theabsence of any reference standard for identification.These variations multiply during storage and furtherprocessing. Hence for herbal drugs and products,standardization should encompass the entire field ofstudy from cultivation of medicinal plant to its clinicalapplication.103Plant materials and herbal remedies derived from themrepresent substantial portion of global market and in thisrespect internationally recognized guidelines for theirquality assessment and quality control are necessary.Standardization and quality control of herbal crudedrugs – Processes and proceduresAccording to WHO (1996a and b, 1992), standardizationand quality control of herbals is the process involved inthe physicochemical evaluation of crude drug coveringaspects, such as selection and handling of crudematerial, safety, efficacy and stability assessment offinished product, documentation of safety and risk basedon experience, provision of product information toconsumer and product promotion. Attention is normallypaid to such quality indices such as:1. Macro and microscopic examination: For Identificationof right variety and search of adulterants.2. Foreign organic matter: This involves removal ofmatter other than source plant to get the drug in pureform.3. Ash values: These are criteria to judge the identity andpurity of crude drug – Total ash, sulphated ash, watersoluble ash and acid insoluble ash etc.4. Moisture content: Checking moisture content helpsreduce errors in the estimation of the actual weight ofdrug material. Low moisture suggests better stabilityagainst degradation of product.5. Extractive values: These are indicative weights of theextractable chemical constituents of crude drug underdifferent solvents environment.6. Crude fibre: This helps to determine the woodymaterial component, and it is a criterion for judging purity.7. Qualitative chemical evaluation: This coversidentification and characterization of crude drug withrespect to phytochemical constituent. It employs differentanalytical technique to detect and isolate the activeconstituents. Phytochemical screening techniques involvebotanical identification, extraction with suitable solvents,purification, and characterization of the activeconstituents of pharmaceutical importance.8. Chromatographic examination: Include identification ofcrude drug based on the use of major chemicalconstituents as markers.9. Quantitative chemical evaluation: To estimate theamount of the major classes of constituents.10. Toxicological studies: This helps to determine thepesticide residues, potentially toxic elements, safetystudies in animals like LD50 and Microbial assay toestablish the absence or presence of potentially harmfulmicroorganisms.The processes mentioned above involves wide array ofscientific investigations, which include physical, chemicaland biological evaluation employing various analytical
104Int. J. Biodvers. Conserv.methods and tools. The specific aims of suchinvestigation in assuring herbal quality are as varied asthe processes employed.are a plethora of analytical methods available. However,it is often difficult to know which is the most appropriate touse, but critical among know analytical tools inmonograph standardization is chromatography.Physical evaluationChromatographyEach monograph contains detailed botanical, macroscopic and microscopic descriptions of the physicalcharacteristics of each plant that can be used to ensureboth identity and purity. Each description is accompaniedby detailed illustrations and photographic images whichprovide visual documentation of accurately identifiedmaterial.Microscopic evaluationFull and accurate characterization of plant materialrequires a thorough physical examination. Microscopicanalyses of plants are invaluable for assuring the identityof the material and as an initial screening test forimpurities.Chemical evaluationThis covers screening, isolation, identification andpurification of the chemical components. Chemicalanalysis of the drug is done to assess the potency ofvegetable material in terms of its active principles. Thechemical screening or tests may include colour reactiontest, which help to determine the identity of the drugsubstance and possible adulteration.Biological evaluationPharmacological activity of certain drugs has beenapplied to evaluate and standardize them. The assays onliving animal and on their intact or isolated organs canindicate the strength of the drug or their preparations.These assays are known as Biological assays orBioassay.Purity determinationChromatography is the science which studies theseparation of molecules based on differences in theirstructure and/or composition. In general, chromatographyinvolves moving a preparation of the materials to beseparated, “the "test preparation”, over a stationarysupport. The molecules in the test preparation will havedifferent interactions with the stationary support leadingto separation of similar molecules. Test molecules whichdisplay tighter interactions with the support will tend tomove more slowly through the support than thosemolecules with weaker interactions. In this way, differenttypes of molecules can be separated from each other asthey move over the support material. Chromatographicseparations can be carried out using a variety ofsupports, including immobilized silica on glass plates(thin layer chromatography), very sensitive HighPerformance Thin Layer Chromatography (HPTLC),volatile gases (gas chromatography), paper (paperchromatography), and liquids which may incorporatehydrophilic, insoluble molecules (liquid chromatography).High performance thin layer chromatography (HPTLC) isa valuable quality assessment tool for the evaluation ofbotanical materials. It allows for the analysis of a broadnumber of compounds both efficiently and costeffectively. Additionally, numerous samples can be run ina single analysis thereby dramatically reducing analyticaltime. With HPTLC, the same analysis can be viewedcollectively in different wavelengths of light therebyproviding a more complete profile of the plant than istypically observed with more specific type of analysis.Quantitative analysisThe most appropriate quantitative analytical method withaccompanying chromatograms is desirable. The primarygoal of the methods is to provide validated methods to beused to quantify the compounds most correlated withpharmacological activity or qualitative markers (Wani,2007).Each monograph includes standards for purity and otherqualitative indices already mentioned above.Control of starting materialAnalytical methodsCritical to compliance with any monograph standard isthe need for appropriate analytical methods fordetermining identity, quality, and relative potency. ThereControl of the starting materials is essential in order toensure reproducible quality of herbal medicinal products(De Smet, 2004; Gaedcke and Steinhoff, 2003; WHO,2002b; Phillipson, 1993). The following points are to beconsidered in the control of starting materials:
Kunle et rbalThe problems associated with unregulated herbalproducts highlight the major public health issues that canarise when their herbal ingredients have not beenauthenticated correctly. Herbal ingredients must beaccurately identified by macroscopic and microscopiccomparison with authentic material or accuratedescriptions of authentic herbs (Houghton, 1998). It isessential that herbal ingredients are referred to by theirbinomial Latin names of genus and species; onlypermitted synonyms should be used. Even whencorrectly authenticated, it is important to realise thatdifferent batches of the same herbal ingredient may differin quality due to a number of factors such as:1. Inter- or intra-species variation: The variation inconstituents is mostly genetically controlled and may berelated to the country of origin.2. Environmental factors: The quality of a herbalingredient can be affected by environmental factor likeclimate, altitude and other conditions under which it wascultivated.3. Time of harvesting: For some herbs the optimum timeof harvesting should be specified as it is known that theconcentrations of constituents in a plant can vary duringthe growing cycle or even during the course of a day.4. Plant part used: Active constituents usually varybetween plant parts and it is not uncommon for a herbalingredient to be adulterated with parts of the plant notnormally utilised. In addition, plant material that has beenpreviously subjected to extraction and is therefore'exhausted' is sometimes used as adulterants to increasethe weight of a batch of herbal ingredient.5. Post-harvesting factors: Storage conditions andprocessing treatments can greatly affect the quality of aherbal ingredient. Inappropriate storage after harvestingcan result in microbial contamination, and processessuch as drying may result in a loss of thermo-labile activeconstituents.Adulteration/substitutionThere are instances when herbal remedies have beenadulterated with other plant material and conventionalmedicines. Reports of herbal products devoid of knownactive constituents have reinforced the need for adequatequality control of herbal remedies.Identity and purityIn order to try to ensure the quality of licensed herbalmedicines, it is essential not only to establish thebotanical identity of a herbal ingredient but also to ensurebatch-to-batch reproducibility. Thus, in addition to105macroscopic and microscopic evaluation, identity testsare necessary. Such tests include simple chemical tests,e.g. colour or precipitation and chromatographic tests.Thin-layer chromatography is commonly used foridentification purposes but for herbal ingredientscontaining volatile oils, a gas–liquid chromatographic testmay be used. Although the aim of such tests may be toconfirm the presence of active principles, it is frequentlythe case that the nature of the active principle has notbeen established. In such instances chemical andchromatographic tests help to provide batch-to-batchcomparability and the chromatogram may be used as a'fingerprint' for the herbal ingredient by demonstrating theprofile of some common plant constituents such asflavonoids, alkaloids and terpenes.Identity and purity ask the most important question “isthe herb the one it should be?” In answering this, a lot ofquality determinants are critically examined. Suchdeterminant as purity and chemical constituents are veryimportant. To prove identity and purity, criteria such astype of preparation, sensory properties, physicalconstants, adulteration, contaminants, moisture, ashcontent and solvent residues have to be checked. Identitycan be achieved by macro- and microscopicalexaminations. Voucher specimens are reliable referencesources. Outbreaks of diseases among plants may resultin changes to the physical appearance of the plant andlead to incorrect identification (De Smet, 1999). At timesan incorrect botanical quality with respect to the labellingcan be a problem. For example, in the 1990’s, a SouthAmerican product labelled as “Paraguay Tea” wasassociated with an outbreak of anticholinergic poisoningin New York. Subsequent chemical analysis revealed thepresence of a class of constituents that was different fromthe metabolites normally found in the plant from whichParaguay tea is made.Assaying for those herbal ingredients with known activeprinciples is another method of ensuring product’s identityand purity. An assay should be established in order to setthe criterion for the minimum accepted percentage ofactive substances. Such assays should, whereverpossible, be specific for individual chemical substances,and high-pressure liquid chromatography and gas–liquidchromatography are the methods of choice. Where suchassays have not been established, then non-specificclassical methods such as titration or colorimetric assaysmay be used to determine the total content of a group ofclosely related compounds.Purity is closely linked with the safe use of drugs anddeals with factors such as values, contaminants (e.g.foreign matter in the form of other herbs), and heavymetals. However, due to the application of improvedanalytical methods, modern purity evaluation alsoincludes microbial contamination, aflatoxins, radioactivity,and pesticide residues. Analytical methods such asphotometric analysis, thin layer chromatography (TLC),high performance liquid chromatography (HPLC), and
106Int. J. Biodvers. Conserv.gas chromatography (GC) can be employed in order toestablish the constant composition ofherbalpreparations. Depending on whether the active principlesof the preparation are known or unknown, differentconcepts such as “normalization versus standardization”have to be applied in order to establish relevant criteriafor uniformity.Content assay is the most difficult area to perform inquality control since in most herbal drugs the activeconstituents are not known. Sometimes markers can beused. In all other cases, where no active constituent ormarker can be defined for the herbal drug, thepercentage extractable matter with a solvent may beused as a form of assay, an approach often seen inpharmacopeias. The choice of the extracting solventdepends on the nature of the compounds involved, andmight be deduced from the traditional uses. For example,when an herbal drug is used to make a tea, the hot waterextractable matter, expressed as milligrams per gram ofair-dried material, may serve this purpose (WHO, 1998b,1996b). A special form of assay is the determination ofessential oils by steam distillation. When the activeconstituents (for example, sennosides in Senna) ormarkers (for example, alky amides in Echinacea) areknown, a vast array of modern chemical analyticalmethods such as ultraviolet/visible spectroscopy(UV/VIS), TLC, HPLC, GC, mass spectrometry (MS), or acombination of GC and MS (GCMS), can be employed(Watson, 1999).Good agricultural/Manufacturing practicesQuality control and the standardization of herbalmedicines also involve several other steps like sourceand quality of raw materials, good agricultural practicesand good manufacturing practices. These practices playa pivotal role in guaranteeing the quality and stability ofherbal preparations (WHO, 2004, 2003, 2000, 1992,1988b; EMEA, 2002; Blumenthal et al., 1998; Robertsand Tyler, 1997). The quality of a plant product isdetermined by the prevailing conditions during growth,and accepted Good Agricultural Practices (GAP) cancontrol this. These include seed selection, growthconditions, fertilizers application, harvesting, drying andstorage. In fact, GAP procedures are integral part ofquality control.Factors such as the use of fresh plants, age and part ofplant collected, period, time and method of collection,temperature of processing, exposure to light, availabilityof water, nutrients, drying, packing, transportation of rawmaterial and storage, can greatly affect the quality, andhence the therapeutic value of herbal medicines. Apartfrom these criteria, factors such as the method ofextraction, contamination with microorganisms, heavymetals, and pesticides can alter the quality, safety, andefficacy of herbal drugs. Using cultivated plants undercontrolled conditions instead of those collected from thewild can minimize most of these factors (Eskinazi et al.,1999; Blumenthal et al., 1998; Bauer, 1998). Sometimes,the active principles are destroyed by enzymic processesthat continue for long periods from collection tomarketing, resulting in a variation of composition. Thus,proper standardization and quality control of both the rawmaterial and the herbal preparations should beconducted.Contaminants of herbal ingredientsHerbal ingredients of high quality should be free frominsects, animal matter and excreta. It is usually notpossible to remove completely all contaminants, hencespecifications should be set in order to limit them:1. Ash values: Incineration of a herbal ingredientproduces ash which constitutes inorganic matter.Treatment of the ash with hydrochloric acid results inacid-insoluble ash which consists mainly of silica andmay be used to act as a measure of soil present. Limitsmay be set for ash and acid-insoluble ash of herbalingredients.2. Foreign organic matter: It is not possible to collect aherbal ingredient without small amounts of related partsof plant or other plants. Standards should be set in orderto limit the percentage of such unwanted plantcontaminants.3. Microbial contamination: Aerobic bacteria and fungi arenormally present in plant material and may increase dueto faulty growing, harvesting, storage or processing.Herbal ingredients, particularly those with high starchcontent, may be prone to increased microbial terococcus, Clostridium, Pseudomonas, Shigella andStreptococcus have been shown to contaminate herbalingredients. It is essential that limits be set for microbialcontamination and the European Pharmacopoeia nowgives non-mandatory guidance on acceptable limits(Barnes et al., 2007).4. Pesticides: Herbal ingredients, particularly those grownas cultivated crops, may be contaminated by DDT(dichlorodiphenyltrichloroethane) or other s orpolychlorinated biphenyls. Limit tests are necessary foracceptable levels of pesticide contamination of herbalingredients. The European Pharmacopoeia includesdetails of test methods together with mandatory limits for34 potential pesticide residues (Barnes et al., 2007).5. Fumigants: Ethylene oxide, methyl bromide andphosphine have been used to control pests whichcontaminate herbal ingredients. The use of ethyleneoxide as a fumigant with herbal drugs is no longerpermitted in Europe (Barnes et al., 2007).6. Toxic metals: Lead, cadmium, mercury, thallium andarsenic have been shown to be contaminants of some
Kunle et al.herbal ingredients. Limit tests for such toxic metals areessential for herbal ingredients.7. Radioactive contamination: There are many sources ofionization radiation, including radionuclides, occurring inthe environment. Hence, a certain degree of exposure isinevitable. (AOAC, 2005; WHO, 2000; De Smet, 1992).8. Other contaminants: As standards increase for thequality of herbal ingredients it is
together synergistically. Herbal medicine or herbalism is the use of herbs or herbal products for their therapeutic or medicinal value. They may come from any part of the plant but are most commonly made from leaves, roots, bark seeds, and flowers. They are eaten, swallowed, drunk, inhaled,
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