Académique Documents
Professionnel Documents
Culture Documents
Quality control for efficacy and safety of herbal cosmetics is of paramount importance. Quality can be defined as the status of a drug that is determined by identity, purity, content, and other chemical, physical, or biological properties, or by the manufacturing processes. Quality control is a term that refers to processes involved in maintaining the quality and validity of a manufactured product. In general, all medicines, whether they are of synthetic or of plant origin, should fulfill the basic requirements of being efficacious and safe, and this can be achieved by suitable clinical trials.
In general, quality control is based on three important pharmacopoeial definitions: 1. Identity: Is the herb the one it should be? 2. Purity: re there contaminants, e.g., in the form of other herbs which should not be there? !. Content or assay: Is the content of active constituents within the defined limits? It is obvious that the content is the most difficult one to assess, since in most herbal drugs the active constituents are un"nown. #ometimes mar"ers can be used which are, by definition, chemically defined constituents that are of interest for control purposes, independent of whether they have any therapeutic activity or not. $o prove identity and purity, criteria such as type of preparation, physical constants, adulteration, contaminants, moisture, ash content and solvent residues have to be chec"ed. The correct identity of the crude herbal material, or the botanical quality, is of prime importance in establishing the quality control of herbal COSMETICS.
1. Identity:
It can be achieved by macro% and microscopical e&aminations. 'oucher specimens are reliable reference sources. (utbrea"s of diseases among plants may result in changes to the physical appearance of the plant and lead to incorrect identification. t times an incorrect botanical quality with respect to the labeling can be a problem. )or e&le, in the 1**+s, a #outh merican product labeled as ,-araguay $ea. was associated with an outbrea" of anticholinergic poisoning in /ew 0or". #ubsequent chemical analysis revealed the presence of a class of constituents that was different from the metabolites normally found in the plant from which -araguay tea is made.
Purity
It is closely lin"ed with the safe use of drugs and deals with factors such ash values, contaminants 1e.g. foreign matter in the form of other herbs2, and heavy metals. 3owever, due to the application of improved analytical methods, modern purity evaluation also includes microbial contamination, aflato&ins, radioactivity, and
pesticide residues. nalytical methods such as photometric analysis, thin layer chromatography 1$452, high performance liquid chromatography 13-452, and gas chromatography 1652 can be employed in order to establish the constant composition of herbal preparations.
3. Content or assay
It is the most difficult area of quality control to perform, since in most herbal drugs the active constituents are not "nown. #ometimes mar"ers can be used. In all other cases, where no active constituent or mar"er can be defined for the herbal drug, the percentage e&tractable matter with a solvent may be used as a form of assay, an approach often seen in pharmacopeias. The choice of the extracting solvent depends on the nature of the compounds involved, and might be deduced from the traditional uses. )or e&le, when a herbal drug is used to ma"e a tea, the hot water e&tractable matter, e&pressed as milligrams per gram of air%dried material, may serve this purpose.
special form of assay is the determination of essential oils by steam distillation. 7hen the active constituents 1e.g. sennosides in Senna2 or mar"ers 1e.g. alkylamides in Echinacea2 are "nown, a vast array of modern chemical analytical methods such as ultraviolet8visible spectroscopy 19'8'I#2, $45, 3-45, 65, mass spectrometry 1:#2, or a combination of 65 and :# 1658:#2, can be employed.
Several r!"le#$ n!t a li%a"le t! $ynt&eti% dr'($ in)l'en%e t&e *'ality !) &er"al dr'($:
1. 3erbal drugs are usually mi&tures of many constituents. 2. $he active principle1s2 is 1are2, in most cases un"nown. 3. #elective analytical methods or reference compounds may not be available commercially. 4. -lant materials are chemically and naturally variable. 5. $he source and quality of the raw material are variable. 6. $he methods of harvesting, drying, storage, transportation, and processing 1for e&le, mode of e&traction and polarity of the e&tracting solvent, instability of constituents, etc.2 have an effect.
Strict guidelines have to be followed for the successful production of a uality herbal drug! mong them are;%
Proper botanical identification, !hytochemical screening, and Standardi"ation
#tandardi<ation involves ad=usting the herbal drug preparation to a defined content of a constituent or a group of substances with "nown therapeutic activity by adding e&cipients or by mi&ing herbal drugs or herbal drug preparations. "otanical extracts
made directly from crude plant material show substantial variation in composition, uality, and therapeutic effects. #tandardi<ed e&tracts are high%quality e&tracts containing consistent levels of specified compounds, and they are sub=ected to rigorous quality controls during all phases of the growing, harvesting, and manufacturing processes.
/o regulatory definition e&ists for standardi<ation of dietary supplements. s a result, the term ,standardi<ation. may mean many different things. #ome manufacturers use the term standardi<ation incorrectly to refer to uniform manufacturing practices> following a recipe is not sufficient for a product to be called standardi<ed. $herefore, the presence of the word ,standardi<ed. on a supplement label does not necessarily indicate product quality. 7hen the active principles are un"nown, mar"er substance1s2 should be established for analytical purposes and standardi<ation. Mar#er substances are chemically defined constituents of a herbal drug that are important for the quality of the finished product Ideally, the chemical mar"ers chosen would also be the compounds that are responsible for the botanical?s effects in the body.
1. Ma%r!$%! i% E,a#inati!n
Organoleptic evaluation (rganoleptic evaluation of drugs refers to the evaluation of a drug by colour, odour, si<e, shape, taste and special features including touch, te&ture etc. #ince the ma=ority of information on the identity, purity and quality of the material can be
drawn from these observations, they are of primary importance before any further testing can be carried out. )or this purpose authentic specimen of the material under study and samples of pharmacopoeial quality should be available to serve as a reference. $his evaluation procedure provides the simplest and quic"est means to establish the identity and purity and thereby ensure quality of a particular sample. If it is found to be devoid of or significantly different from the specified sensory characters li"e colour, consistency, odour, etc., it is considered as not fulfilling the requirements. &owever 'udgment based on the sensory characteristics li$e odour, taste etc!, may vary from person to person and time to time based on individual(s nature! #o the description of this features are very difficult so that often the characteristic li"e odour and taste can only described as BcharacteristicB and reference made to the analystBs memory. /o preliminary treatment is necessary for evaluating the sample in this manner e&cepting the softening and stretching of the wrin"led and contracted leaves and flowers etc.
-. Mi%r!$%! i% Eval'ati!n Quality control of herbal drugs has traditionally been based on appearance and today microscopic evaluation is indispensable in the initial identification of herbs, as well as in identifying small fragments of crude or powdered herbs, and detection of foreign matter and adulterants. primary visual evaluation, which seldom needs more than a simple magnifying lens, can be used to ensure that the plant is of the required species, and that the right part of the plant is being used. t other times, microscopic analysis is needed to determine the correct species and8or that the correct part of the species is present. )or instance, pollen morphology may be used in the case of flowers to identify the species, and the presence of certain microscopic structures such as leaf stomata can be used to identify the plant part used. lthough this may seem obvious, it is of prime importance, especially when different parts of the same plant are to be used for different treatments. Stinging nettle )*rtica urens+ is a classic example where the aerial parts are used to treat rheumatism, while the roots are applied for benign prostate hyperplasia.
0. /eter#inati!n !) A$&
$o determine ash content the plant material is burnt and the residual ash is measured as total and acid%insoluble ash. $otal ash is the measure of the total amount of material left after burning and includes ash derived from the part of the plant itself and acid%insoluble ash. $he latter is the residue obtained after boiling the total ash with dilute hydrochloric acid, and burning the remaining insoluble matter. $he second procedure measures the amount of silica present, especially in the form of sand and siliceous earth.
:aterials of vegetable origin tend to show much higher levels of microbial contamination than synthetic products and the requirements for microbial contamination in the Curopean -harmacopoeia allow higher levels of microbial contamination in herbal remedies than in synthetic pharmaceuticals. $he allowed contamination level may also depend on the method of processing of the drug. -or example, higher contamination levels are permitted if the final herbal preparation involves boiling with water! $he presence of fungi should be carefully investigated and8or monitored, since some common species produce to&ins, especially aflato&ins. flato&ins in herbal drugs can be dangerous to health even if they are absorbed in minute amounts. flato&in%producing fungi sometimes build up during storage. -rocedures for the determination of aflato&in contamination in herbal drugs are published by the 73(. fter a thorough clean%up procedure, $45 is used for confirmation. Certain plant constituents are susceptible to chemical transformation by contaminating microorganisms
be a health ris". $herefore, at present, no limits are proposed for radioactive contamination.
5. Analyti%al Met&!d$
$he quantitative determination of constituents has been made easy by recent developments in analytical instrumentation. Eecent advances in the isolation, purification, and structure elucidation of naturally occurring metabolites have made it possible to establish appropriate strategies for the determination and analysis of quality and the process of standardi<ation of herbal preparations. 5lassification of plants and organisms by their chemical constituents is referred to as chemota&onomy. $45, 3-45, 65, quantitative $45 1Q$452, and high%performance $45 13-$452 can determine the homogeneity of a plant e&tract. (ver%pressured layer chromatography 1(-452, infrared and 9'%'I# spectrometry, :#, 65, liquid chromatography 1452 used alone, or in combinations such as 658:#, 458:#, and :#8:#, and nuclear magnetic resonance 1/:E2, are powerful tools, often used for standardi<ation and to control the quality of both the raw material and the finished product. $he results from these sophisticated techniques provide a chemical fingerprint as to the nature of chemicals or impurities present in the plant or e&tract.
C&e#i%al C!n$tit'ent$
#andalwood oil is obtained from the heartwood of the plant. $his volatile oil contains about *+A alpha% and beta%santalols with a variety of minor components including sesquiterpene hydrocarbons 1about @A2. $he santalols are responsible for the pleasant odor of sandalwood, although 2%furfuryl pyrrole also may contribute an effect. $he seeds yield about I+A of a viscid, dar" red, fi&ed oil. $his oil contains stearolic acid and santalbic acid. 6as chromatography fingerprinting of sandalwood oils has been used successfully in light of the comple& nature of the components of the oils
C'ltivati!n
$o produce commercially valuable sandalwood with high levels of fragrance oils, harvested santalum trees have to be at least H+ years of age, but O+ or above is preferred. 3owever, inferior sandalwood produced from trees at !+ years old can still fetch a decent price due to the demand for real sandalwood. 9nli"e most trees, sandalwood is harvested by toppling the entire santalum tree instead of sawing them down at the trun". $his way, valuable wood from the stump and root can also be sold or processed for oil. #andalwood oil is obtained from the steam distillation of chips and billets cut from the heartwood of the #andalwood 1#antalum album2 tree.
#$erapeutic properties $he therapeutic properties of sandalwood oil are antiphlogistic, antiseptic, antispasmodic, astringent, carminative, diuretic, emollient, e&pectorant, sedative and tonic.
$his rela&ing oil has a harmoni<ing and calming effect which reduces tension and confusion and is ideal for use in depression, hectic daily lifestyles and states of fear, stress, nervous e&haustion, chronic illness and an&iety. It is very useful for any chest complaints as it has a pronounced effect on the mucus membranes of both the pulmonary as well as genito%urinary tract % ma"ing it very effective for complaints of the urinary tract as well. 5hronic chest infections, sore throats and dry coughs as well as bronchitis and asthma can benefit greatly from this oil, as well as cystitis and bladder infections, also helpful with se&ual problems such as frigidity and impotence. (n the s"in, sandalwood oil relieves itching and inflammation of the s"in, and is most effective in relieving dehydrated s"in % ma"ing it great for anti%ageing s"incare % and the astringent action has a great toning effect and is also used with great results in oily s"in conditions and to prevent the s"in from forming ugly scars and for fighting dry ec<ema. #andalwood oil can be helpful for the nervous system, for chest and urinary tract infections, for se&ual problems and for s"in care. %urners and vapori&ers' In vapor therapy, sandalwood oil can be used for its aphrodisiac effect, to help clear bronchitis, coughs, chest infections, asthma, insomnia, irritability, nervous tension, stress, tension, for rela&ing and as an insect repellant. %lended massage oil or in t$e (at$ s a blended massage oil or diluted in the bath, sandalwood oil can assist with bladder infections as well as chest infections and bronchitis, coughs, dry ec<ema, insomnia, forming scar tissue, irritability, nervous tension, stress, tension, as an aphrodisiac and for rela&ing. )argle It can be effective when diluted and used as a gargle for a sore or dry throat. *otions or creams 7hen used in a lotion or cream sandalwood oil can assist with chapped, dry or inflamed s"in and has wonderful moisturi<ing and hydrating properties, which are great for anti% ageing s"incare. $he toning effect is useful when fighting oily s"in.
REFRENCE:
9EBSITES:
1. www.bio%medicine.org8 2. www.pharmainfo.net 3. www.essentialoils.co.<a 4. faculty."su.edu.sa8 5. www.drugs.com 6. www.en.wi"ipedia.org
BOO<S:
1. Quality 5ontrol of 3erbal Drugs 12++@2 by Pulok + ,uk$er-ee
2. $e&tboo" (f Industrial -harmacognosy 12..5/ (y Kalia