QUALITY CONTROL OF HERBAL COSMETICS •
Qual Qualit ity y cont contro roll for for effi effica cacy cy and safet afety y of herb herbal al cosm cosmet etic icss is of para paramo moun untt 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 fulfi fulfill ll the the basi basicc requ require ireme ment ntss of bein being g effic efficaci aciou ouss and and safe, safe, and and this this can be achieved by suitable clinical trials.
In general, quality control is based on three important pharmacopoeial pharmacopoeial definitions:
1. Identity: Is the herb the one it should be? 2. Purity: Are there contaminants, e.g., in the form of other herbs which should not be there? 3. Content or assay: Is the content of active constituents within the defined limits?
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It is obviou obviouss that the content content is the the most most difficult difficult one one to assess, assess, since since in most herbal drugs the active constituents are unknown. Sometimes markers 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.
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To prov provee iden identi tity ty and and puri purity ty,, crit criter eria ia such such as type type of prep prepar arat atio ion, n, phys physic ical al constants, adulteration, contaminants, moisture, ash content and solvent residues have to be checked. 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 examinations. Voucher specimens are reliable reference sources. sources. Outbreaks Outbreaks of diseases diseases among plants may result in changes changes to the physical appearance of the plant and lead to incorrect identification. At times an incorrect botanical quality with respect to the labeling can be a problem. For example, in the 1990s, a South American product labeled as “Paraguay Tea” was associated with an outbreak of anticholinergic poisoning in New York. Subsequent chemical analysis revealed the presence of a class of constituents that was different from the metabolites normally found in the plant from which Paraguay tea is made.
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Purity
It is closely linked with the safe use of drugs and deals with factors such ash values, contaminants (e.g. foreign matter in the form of other herbs), and heavy metals. Howeve However, r, due due to the applic applicatio ation n of improv improved ed analyt analytical ical method methods, s, modern modern purity purity evaluat evaluation ion also also includ includes es microb microbial ial contam contamina inatio tion, n, aflatox aflatoxins ins,, radioa radioactiv ctivity ity,, and
pesti pesticid cidee residu residues. es. Analyt Analytical ical method methodss such such as photom photometri etricc analys analysis, is, thin thin layer layer chromatography (TLC), high performance liquid chromatography (HPLC), and gas chromatography (GC) can be employed in order to establish the constant composition of herbal preparations.
3. Content or or as assay It is the most difficult area of quality control to perform, since in most herbal drugs the active constituents are not known. Sometimes markers can be used. In all other cases, where no active constituent or marker can be defined for the herbal drug, the percentage extractable 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 . For example, when a herbal drug is used to make a tea, the hot water extractable matter, expressed as milligrams per gram of air-dried material, may serve this purpose.
A special form of assay is the determination of essential oils by steam distillation. When the active constituents (e.g. sennosides in Senna) or markers markers (e.g. alkylamides in Echinacea ) are known, a vast array of modern chemical analytical methods such as ultraviolet/visible spectroscopy (UV/VIS), TLC, HPLC, GC, mass spectrometry (MS), or a combination of GC and MS (GC/MS), can be employed.
Several problems not applicable to synthetic drugs influence the quality of herbal drugs: 1. Herbal drugs are usually mixtures of many constituents. 2. The active principle(s) is (are), in most cases unknown. Selecti tive ve analy analytic tical al meth method odss or refere referenc ncee comp compou ound ndss may not not be avail availab able le 3. Selec commercially. 4. Plant materials are chemically and naturally variable. 5. The source and quality of the raw material are variable. 6. The methods of harvesting, drying, storage, transportation, and processing (for example, mode of extraction and polarity of the extracting solvent, instability of constituents, etc.) have an effect.
Strict Strict guidel guideline iness have have to be follow followed ed for the succe successf ssful ul produ product ction ion of a quality herbal drug. Among them are:• • •
Proper botanical identification, identification, Phytochemical Phytochemical screening , screening , and Standardization
Standardization involves adjusting the herbal drug preparation to a defined content of a constit constituen uentt or a group group of subst substanc ances es with with known known therap therapeut eutic ic activi activity ty by adding adding excipients or by mixing herbal drugs or herbal drug preparations. Botanical extracts
made directly from crude plant material show substantial variation in composition, quality, and therapeutic effects . •
Stan Standa dard rdize ized d extra extracts cts are high high-q -qua ualit lity y extr extract actss cont contain ainin ing g cons consis isten tentt leve levels ls of specified compounds, and they are subjected to rigorous quality controls during all phases of the growing, harvesting, and manufacturing processes.
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No regu regulat lator ory y defi defini nitio tion n exis exists ts for stan standa dard rdiza izati tion on of dieta dietary ry supp supplem lemen ents ts.. As a resul result, t, the the term term “sta “stand ndard ardiza izati tion on”” may mean mean many many diff differ eren entt thin things gs.. Some Some manu manufac factu turer rerss use use the the term term stan standa dard rdiza izatio tion n inco incorre rrect ctly ly to refer refer to unifo uniform rm manufacturing practices; following a recipe is not sufficient for a product to be called called standa standardi rdized zed.. Therefo Therefore, re, the presen presence ce of the word word “stan “standar dardiz dized” ed” on a supplement label does not necessarily indicate product quality. When the active principles are unknown, marker substance(s) should be established for analytical purposes and standardization. • Marker substances are chemically defined constituents of a herbal drug that are important for the quality of the finished product. Ideally, the chemical markers chosen would also be the compounds that are responsible for the botanical’s effects in the body.
There are two types of standardization In the the first first categ categor ory y, “true” standa standardi rdizati zation, on, a defini definite te phytoch phytochemic emical al or group group of constituents is known to have activity. Ginkgo with its 26% ginkgo flavones and 6% terpenes is a classic example. These products are highly concentrated and no longer represent the whole herb, and are now considered as phytopharmaceuticals. In many cases they are vastly more effective than the whole herb. The other type of standardization is based on manufacturers guaranteeing the prese presence nce of a certain certain percent percentage age of marker marker compound compounds; s; these these are are not indicato indicators rs of therapeutic activity or quality of the herb.
Parameters for Quality Control of Herbal cosmetics
Macroscopic Examination
Organoleptic evaluation
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Orga Organo nole lept ptic ic evalua evaluati tion on of drugs drugs refer referss to the evalu evaluati ation on of a drug drug by colour colour,, odour, size, shape, taste and special features including touch, texture etc. Since the majority 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. • For For this this purpo purpose se authe authent ntic ic specim specimen en of the mater material ial unde underr stud study y and samples samples of pharmacopoeial quality should be available to serve as a reference. • This This evaluatio evaluation n procedu procedure re provide providess the simples simplestt and quickes quickestt means to estab establis lish h the identity and purity and thereby ensure quality of a particular sample. •
If it is found found to be be devoid devoid of or sign signific ificant antly ly differe different nt from from the speci specified fied sens sensory ory characters like colour, consistency, odour, etc., it is considered as not fulfilling the requirements. • However judgment based on the sensory characteristics characteristics like odour, odour, taste etc., may vary from person to person and time to time based on individual's nature. So the description of this features are very difficult so that often the characteristic like odour and taste can only described as 'characteristic' and reference made to the analyst's memory. • No prelim prelimin inary ary treatm treatmen entt is necess necessary ary for evalu evaluati ating ng the sample sample in this this manne manner r excepting the softening and stretching of the wrinkled and contracted leaves and flowers etc.
2. Microscopic Evaluation •
Qual Quality ity contro controll of herbal herbal drugs drugs has has trad traditi ition onall ally y been been based based on appe appeara aranc ncee and and today microscopic evaluation is indispensable in the initial identification of herbs, as well as in identifying identif ying small fragments of crude or powdered herbs, and detecti on of foreign matter and adulterants. A 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. At other times, microscopic analysis is needed to determine the correct species and/or that the correct part of the species is present. For instance, pollen morphology may be used in the the case case of flow flower erss to iden identi tify fy the the speci species es,, and and the the pres presen ence ce of certai certain n microscopic structures such as leaf stomata can be used to identify the plant part used. Although 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 (Urtica urens) is a classic example where the aerial parts are used to treat rheumatism, while the roots are applied for benign prostate hyperplasia .
3. Determination of Foreign Matter Herbal drugs should be made from the stated part of the plant and be devoid of other parts of the same plant or other plants. They should be entirely free from moulds or insects, including excreta and visible contaminant such as sand and stones, poisonous and harmful foreig foreign n matter matter and chemical chemical residu residues. es. Animal Animal matter matter such such as insects insects and “invis “invisibl ible” e” micro microbi bial al cont contami amina nant nts, s, whic which h can prod produc ucee toxi toxins ns,, are also also among among the the poten potenti tial al contaminants of herbal medicines. Macroscopic examination can easily be employed to determine the presence of foreign matter, although microscopy is indispensable in certain specia speciall cases cases (for (for exampl example, e, starch starch delibe deliberate rately ly added added to “dilut “dilute” e” the plant plant materia material). l). Furthermore, when foreign matter consists, for example, of a chemical residue, TLC is often needed to detect the contaminants.
4. Determination of Ash To determine ash content the plant material is burnt and the residual ash is measured as total and acid-insoluble ash. Total ash is the measure of the total amount of material left after burning and includes includes ash derived derived from the part of the plant itself and acid-insolu acid-insoluble ble ash. The latter is the residue obtained after boiling the total ash with dilute hydrochloric acid, and burning the remaining insoluble matter. The second procedure measures the amount of silica present, especially in the form of sand and siliceous earth.
5. Determination of Heavy Metals •
Contamin aminat atiion by toxic metals tals can eith ither be accid ccideental or inten tentional. al. Contam Contaminat ination ion by heavy heavy metals metals such such as mercury mercury,, lead, lead, copper copper,, cadmiu cadmium, m, and arse arseni nicc in herb herbal al reme remedi dies es can can be attr attrib ibut uted ed to many many caus causes es,, incl includ udin ing g environmental pollution, and can pose clinically relevant dangers for the health of the user and should therefore be limited. • A simpl simple, e, straig straight htfo forw rward ard determ determin inati ation on of heav heavy y metal metalss can be found found in many pharma pharmacop copeias eias and is based based on color color reactio reactions ns with with special special reagent reagentss such such as thioacetamide or diethyldithiocarbamate, and the amount present is estimated by comparison with a standard. • Inst Instru rume ment ntal al analy analyse sess have to be empl employ oyed ed when when the the metals metals are prese present nt in trace trace quantities, in admixture, or when the analyses have to be quantitative. The main meth method odss comm common only ly used used are are atomic atomic absorptio absorption n spectrop spectrophoto hotometr metryy (AAS (AAS)) , inductively coupled plasma (ICP) and neutron activation analysis (NAA) .
6. Determination of Microbial Contaminants and Aflatoxins •
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Medi edicin cinal plant ants may be associated ted with ith a broad variety iety of micro crobial cont contam amin inan ants ts,, repr repres esen ented ted by bacte bacteria ria,, fung fungi, i, and and viru viruse ses. s. Inev Inevita itabl bly y, this this microbiolog microbiological ical background background depends on several several environment environmental al factors and exerts an important impact on the overall quality of herbal products and preparations. Herbal Herbal drugs drugs normal normally ly carry carry a number number of bacteri bacteriaa and molds molds,, often often originat originating ing in in the soil. Poor methods of harvesting, cleaning, drying, handling, and storage may also cause additional contamination, as may be the case with Escherichia coli or Salmonella spp. While a large range of bacteria and fungi are from naturally occurring microflora, aerobic spore-forming bacteria frequently predominate. Labora Laboratory tory proce procedur dures es investi investigat gating ing microb microbial ial contami contaminat nation ionss are laid down down in the well-kn well-known own pharmaco pharmacopeia peias, s, as well well as in the WHO guidel guideline ines. s. In general general,, a complete complete procedure procedure consists consists of determining determining the total aerobic microbial microbial count, count, the total fungal count, and the total Enterobacteriaceae count, together with tests for the the pres resence ence of Escheri Escherichia chia coli, Staphylo Staphylococc coccus us aureus aureus, Shigella , and Pseudomonas aeruginosa aeruginosa and Salmonella spp. The European Pharmacopoeia also specifi specifies es that that E. spp. shou should ld be abse absent nt from from herb herbal al E. coli coli and Salmonella spp. preparations. However it is not always these two pathogenic bacteria that cause clini clinical cal prob problem lems. s. For For exam exampl ple, e, a fatal fatal case case of listeriosis was was caus caused ed by cont contam amin inati ation on of alfalf alfalfaa table tablets ts with with the the Gram Gram posi positiv tivee bacil bacillu luss Listeria monocytogenes.
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Mate Materi rial alss of vege vegeta tabl blee orig origin in tend tend to show show much much high higher er leve levels ls of micr microb obia iall cont contam amin inati ation on than than synt synthe hetic tic prod produc ucts ts and and the the requi requirem remen ents ts for for micro microbi bial al contamination in the European Pharmacopoeia allow higher levels of microbial contaminatio contamination n in herbal remedies than in synthetic synthetic pharmaceuticals. pharmaceuticals. The allowed allowed contamination level may also depend on the method of processing of the drug. For example, higher contamination levels are permitted if the final herbal preparation preparation involves boiling with water.
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The The pres presen ence ce of fung fungii shou should ld be carefu carefully lly inves investi tiga gated ted and/o and/orr moni monito tored red,, sinc sincee some common species produce toxins, especially aflatoxins. Aflatoxins Aflatoxins in herbal drugs can be dangerous to health even if they are absorbed in minute amounts. Aflatoxin-producing fungi sometimes build up during storage. Procedures for the determination of aflatoxin contamination in herbal drugs are published by the WHO. After a thorough clean-up procedure, TLC is used for confirmation. Certai Certain n plant plant consti constitue tuents nts are susce susceptib ptible le to che chemic mical al transf transform ormati ation on by contaminating microorganisms. microorganisms.
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7. Determination of Pesticide Residues •
Even Even thoug though h ther theree are are no serio serious us repor reports ts of toxi toxici city ty due to the the pres presen ence ce of pesticides and fumigants, it is important that herbs and herbal products are free of these chemicals or at least are controlled for the absence of unsafe levels. Herbal drugs are liable to contain pesticide pesticide residues, residues, which accumulate from agricultural agricultural practices, such as spraying, treatment of soils during cultivation, and administering of fumigants during storage. However, it may be desirable to test herbal drugs for broad groups in general, rather than for individual pesticides. Many pesticides contain chlorine in the molecule, which, for example, can be measured by analysis of total organic chlorine. In an analogous analogous way, insecticides insecticides containing containing phosphate phosphate can be detected detecte d by measuring total organic phosphorus. • Samples Samples of herb herbal al material material are are extracte extracted d by a standar standard d proced procedure ure,, impuriti impurities es are removed by partition and/or adsorption, and individual pesticides are measured by GC, MS, or GC/MS. Some simple procedures have been published by the WHO and the Europe European an Pharma Pharmacop copoeia oeia has laid down general general limits limits for pestici pesticide de residues in medicine.
8. Determination of Radioactive Contamination There are many sources of ionization ionization radiation, including including radionuclides radionuclides,, occurring occurring in the the envi enviro ronm nmen ent. t. Henc Hencee a certa certain in degr degree ee of expo exposu sure re is inev inevit itab able. le. Dang Dangero erous us contamination, however, may be the consequence of a nuclear accident. The WHO, in close close cooper cooperatio ation n with with several several other other intern internatio ational nal organ organizat ization ions, s, has develo developed ped guidelines in the event of a widespread contamination by radionuclides resulting from major nuclear accidents. These publications emphasize that the health risk, in general, due to radioactive radioactive contamination contamination from naturally occurring occurring radio nuclides nuclides is not a real concern, but those arising from major nuclear accidents such as the nuclear accident in Chernobyl, may be serious and depend on the specific radionuclide, the level of contamination, and the quantity of the contaminant consumed. Taking into account the quantity of herbal medicine normally consumed by an individual, they are unlikely to
be be a healt health h risk. risk. Ther Therefo efore, re, at pres presen ent, t, no limit limitss are prop propos osed ed for for radi radioa oact ctiv ivee contamination.
9. Analytical Methods The The quan quanti titat tativ ivee deter determi mina nati tion on of cons constit titue uent ntss has has been been made made easy easy by recen recentt deve develo lopm pmen ents ts in analy analytic tical al inst instru rume ment ntat atio ion. n. Rece Recent nt adva advanc nces es in the the isol isolati ation on,, 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 standardization of herbal preparations. Classification of plants and organ organism ismss by their their chemic chemical al constit constituen uents ts is referred referred to as chemota chemotaxon xonomy omy.. TLC, TLC, HPLC, HPLC, GC, quanti quantitati tative ve TLC (QTLC) (QTLC),, and high-p high-perfo erforma rmance nce TLC (HPTLC (HPTLC)) can determine the homogeneity of a plant extract. Over-pressured layer chromatography (OPLC), infrared and UV-VIS spectrometry, MS, GC, liquid chromatography (LC) used alone, or in combinations such as GC/MS, LC/MS, and MS/MS, and nuclear magnetic resonance (NMR), are powerful tools, often used for standardization and to control the quality of both the raw material and the finished product. The results from these these sophi sophistic sticated ated technique techniquess provid providee a chemic chemical al finger fingerpri print nt as to the nature nature of chemicals or impurities present in the plant or extract.
EXAMPLES OF HERBAL DRUGS: Hair Care Amla Hair Oil • •
Coconut Hair Oil
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Henna Powder Dye Almond Hair Oil
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Oral Care Meswak Tooth Paste • Skin Care Herbal Fairness Cream • Petroleum Jelly • Personal Care Liquid Handwash • Antiseptic (Disinfectant) • Food Products Peanut Butter • •
Instant Powder Drink
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Instant Powder Drink 45 gm/9gm/5gm
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Flavoring Essence & Food Colors
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Rose Syrup & Rose/Kewra Water Water
UTILIZATION UTILIZATION OF SANDALWOOD OIL Sandal Sandalwoo wood d oil is an essential essential oil obtain obtained ed from from the heartwo heartwood od of the Sandalwood (Santa (Santalum lum album) album) tree. tree. Sandal Sandalwoo wood d oil is used used in perfum perfumes, es, cosmet cosmetics ics,, and sacred sacred unguents. Sandalwood is the name for several fragrant woods. woods. From the Sanskrit candanam the name is borro borrowe wed d as the the Gree Greek k sand sandan anon on.. The The local local name name in Indonesia and Malaysia is "Cendana" (pronounced approximately /t ʃ əndаna/ əndаna/ in IPA). IPA). In Kannada it is Sri Gandha and in Hindi it is Chandan (Chondon in Bengali or other eastern Indian languages). In Tamil it is called "Chandanam".
Chemical Constituents Sandalwood oil is obtained from the heartwood of the plant. This volatile oil contains about about 90% alphaalpha- and beta-sa beta-santa ntalol lolss with with a variety variety of minor minor compon component entss includ including ing sesquiterpene hydrocarbons (about 6%). The santalols are responsible for the pleasant odor of sandalwood, although 2-furfuryl pyrrole also may contribute an effect. The seeds yield about 50% of a viscid, dark red, fixed oil. This oil contains stearolic acid and santalbic acid. Gas chromatography fingerprinting of sandalwood oils has been used successfully in light of the complex nature of the components of the oils
Cultivation To produc producee commerc commerciall ially y valuab valuable le sandal sandalwoo wood d with with high high levels levels of fragran fragrance ce oils, oils, harvested santalum trees have to be at least 40 years of age, but 80 or above is preferred. preferred. However, inferior sandalwood produced from trees at 30 years old can still fetch a decent price due to the demand for real sandalwood. Unlike most trees, sandalwood is harvested by toppling the entire santalum tree instead of sawing them down at the trunk. This way, valuable wood from the stump and root can also be sold or processed for oil. Sandalwood oil is obtained from the steam distillation of chips and billets cut from the heartwood of the Sandalwood (Santalum album) tree.
Uses And Utilization Of Sandalwood Oil
Therapeutic properties
The therapeutic properties of sandalwood oil are antiphlogistic, antiseptic, antispasmodic, astringent, carminative, diuretic, emollient, expectorant, sedative and tonic.
This relaxing oil has a harmonizing and calming effect which reduces tension and confusion and is ideal for use in depression, hectic daily lifestyles and states of fear, stress, nervous exhaustion, chronic illness and anxiety. anxiety. 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 - making it very effective for complaints of the urinary tract as well. Chronic 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 sexual problems such as frigidity and impotence. On the skin, sandalwood oil relieves itching and inflammation of the skin, and is most effective in relieving dehydrated skin - making it great for anti-ageing skincare - and the astringent action has a great toning effect and is also used with great results in oily skin conditions and to prevent the skin from forming ugly scars and for fighting dry eczema. Sandalwood oil can be helpful for the nervous system, for chest and urinary tract infections, for sexual problems and for skin care. Burners and vaporizers: In vapor therapy, sandalwood oil can be used for its aphrodisiac effect, to help clear bronchitis, coughs, chest infections, asthma, insomnia, irritability irritabilit y, nervous tension, stress, tension, for relaxing and as an insect repellant.
Blended massage oil or in the bath As 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 eczema, insomnia, forming scar tissue, irritabilit y, nervous tension, stress, tension, as an aphrodisiac and for relaxing. Gargle It can be effective when diluted and used as a gargle for a sore or dry throat. Lotions or creams When used in a lotion or cream sandalwood oil can assist with chapped, dry or inflamed skin and has wonderful moisturizing and hydrating properties, which are great for antiageing skincare. The toning effect is useful when fighting oily skin.
REFRENCE:
WEBSITES: 1. www.bio-medicine.org/ 2. www.pharmainfo.net 3. www.essentialoils.co.za 4. faculty.ksu.edu.sa/ 5. www.drugs.com 6. www.en.wikipedia.org
BOOKS: 1. Quality Control of Herbal Drugs (2006) by Pulok K Mukherjee 2. Textbook Of Industrial Pharmacognosy (2005) by Kalia
