Research Papers
Research Papers
Research Papers
ABSTRACT
For several decades pharmacist have been aware of the need to protect their products against
microbial contamination but it is only during the last one or perhaps two decades the serious
thought of has been applied to the science of preservation. Preservatives are commonly used as
additives in pharmaceutical products, food and cosmetics. Some of the liquid preparations are
susceptible to microbial contamination because of the nature of ingredients present in it. Such
preparations are protected by preservatives which avoids degradation and alternation of the
product. A preservative is a natural or synthetic chemical added to various products which helps
to prevent microbial decomposition. Present article deals with the study of ideal properties,
classification, and mechanism of action, pharmaceuticals applications and its impacts on health
of various preservatives used in pharmaceuticals.
Introduction:
fumigatus
Cuminum cyminum (Family: Cuminaldehyde Antibacterial against Gram-
Apiaceae) negative bacteria like E. Coli
Curcuma Longa (Family: Curcumin I, Curcumin II and Antibacterial and Antifungal,
Zingiberaceae) Curcumin III active against Candida
albicans, C. krusei and C.
parasitosis
(Family: Myrsinaceae) deglucocyclamin and Cryptococcus neoformans
cyclamen
Desmodium canum (Family: Isoflavanones, named Antibacterial and Antifungal,
Fabaceae) desmodianones A, B and C active against B.subtilis, S.
aureus, M. smegmatis, E. coli,
C. albicans and Neurospora
crassa.
Eriosema tuberosum (Family: Eriosemaones A-D, Flemicin Antifungal Cladosporium
Leguminosae) D cucumerinum and C. albicans
Euphorbia tuckeyana 24-Methylenecycloartanol and Antibacterial and Antifungal,
(Family: Euphorbiaceae) beta-sitosterol Active against Gram positive
bacteria and C. albicans.[23]
Garcinia kola (Family: Polyisoprenyl benzophenone Antibacterial and Antifungal
Clusiaceae or Guttiferae) (kolanone), active against E. coli, C.
hydroxybiflavanonols albicans, S.Aureus
Glehnia littoralis (Family: 1,9-Heptadecadiene-4,6- Antibacterial and Antifungal,
Apiaceae) diyne3,8,11-triol and active against P. aeruginosa, E.
(10E)1,10- heptadecadiene- coli, S. aureus, B. subtilis and
4,6-diyne-3,8,9- triol C. albicans.
Juniperus species (Family: Alpha-terpineol (88.4%). Antibacterial and Antifungal,
Cupressaceae) active against P. aeruginosa, E.
coli, B. subtilis and C.
albicans
Hypericum roeperanum 5-O-methyl-2- Anti Fungal, active against
(Family: Hypericaceae) deprenylrheediaxanthone, Cladosporium cucumerinum
roeperanone and C. albicans.
Isopyrum thalictroides Tertiary alkaloid and Antibacterial and Antifungal
(Family: Ranunculaceae) quaternary alkaloid
Kigelia pinnata (Family: Naphthoquinones, isopinnatal, Antibacterial and Antifungal,
Bignoniaceae) lapachol, phenylpropanoids, active against
pcoumaric and ferulic acid Corynebacterium diphtheria,
Pullularia pullularis[24]
Landolphia owrrience Steroids, saponins, tannins Antibacterial, Antifungal and
antiherpes virus
Cumin oil Cuminum cyminum of Pinene, phellandrene, Antioxidant,
(Family:Umbelliferae) Limonene antispasmodic,
carminative, stimulant
and tonic
Eucalyptus Oil Eucalyptus globulus A-pinene, b-pinene, Anti oxidant, a
(Family:Myrtaceae) terpinen-4-ol, cooling and
aromadendrene, deodorizing effect on
epiglobulol, the body,
Fennel Oil Foeniculum vulgare A-pinene, myrcene, Antioxidant,
(Family:Umbelliferae) limonene, 1,8-cineole antiseptic,
antispasmodic,
carminative,
depurative, diuretic
Lemon oil Citrus limonum Ascorbic acid Antioxidant, reducing
(Family:Rutaceae) (vitamin c), blood pressure
aterpinene, linalool,
bbisabolene,
Sage oil Salvia officinalis Chlorgenic acid, Anti oxidant, anti
(Family: Labiatae) flavones, flavonoid biotic, anti fungal,
glycoside,cineole, anti spasmodic,
thujone astringent
Thyme Oil Thymus vulgaris Thymol, a-thujone, Antioxidant,
(Family: Labiatae) apinene, linalool antiseptic, antifungal
Marjoram Oil Origanum marjorana Sabinene, a-terpinene, Anti oxidant,
(Family: Labiatae) linalool, cis-sabinene analgesic,
hydrate, l terpinen-4- antispasmodic,
ol antiseptic, antiviral,
bactericidal
Oregano oil Origanum vulgare Phenolic acids and Antioxidant, antiviral,
(Family: Labiatae) flavonoids antibacterial[26]
Preservative Toxicity
Cinnamon oil Burning sensation in mouth, chest and
stomach, gastrointestinal problems and
sleeplessness persisting for 5 hrs.
Capsicum species Powerful irritant produces erythematic and
burning without blistering human skin,
produces severe gastritis and diarrhea.[29]
Curcuma Longa Gastric ulceration due to reduction in the
mucin content of gastric juice, fairly nontoxic,
CHEMICAL PRESERVATIVES:
ETHYL ALCOHOL:
Synonyms: Antimicrobial preservative; disinfectant;
skin penetrant; solvent. -Applications in
Ethanolum (96 per centum); ethyl alcohol; ethyl
hydroxide; grain alcohol; methyl carbinol.
Pharmaceutical Formulation or Technology
Ethanol and aqueous ethanol solutions of
Chemical Name: Ethanol various concentrations are widely used in
Empirical Formula and Molecular pharmaceutical formulations and cosmetics.
Weight: C2H6O; 46.07 Although ethanol is primarily used as a
solvent, it is also employed as a disinfectant,
Structural Formula: and in solutions as an antimicrobial
preservative. Topical ethanol solutions are
used in the development of transdermal drug
delivery systems as penetration enhancers.
Ethanol has also been used in the
development of transdermal preparations as
a co-surfactant.
Description:
In the BP 2009, the term ‗ethanol‘ used
without other qualification refers to ethanol
containing 599.5% v/v of C2H6O.The term
Functional Category: ‗alcohol‘, without other qualification, refers
to ethanol 95.1-96.9%v/v. Where other
strengths are intended, the term ‗alcohol‘ or In acidic conditions, ethanol solutions may
‗ethanol‘ is used, followed by the statement react vigorously with oxidizing materials.
of the strength. In the PhEur 6.0, anhydrous Mixtures with alkali may darken in color
ethanol contains not less than99.5% v/v of owing to a reaction with residual amounts of
C2H6O at 208C. The term ethanol (96%) is aldehyde.[6]
used to describe the material containing
water and 95.1- 96.9% v/v of C2H6O at
ALPHA TOCOPHEROL:
208C.In the USP 32, the term ‗dehydrated
alcohol‘ refers to ethanol 599.5% v/v. The Synonyms:
term ‗alcohol‘ without other qualification
Copherol F1300; 3,4-dihydro-2,5,7,8-
refers to ethanol 94.9-96.0% v/v. In the JP
tetramethyl-2-(4,8,12-trimethyltridecyl)-2H-
XV, ethanol (alcohol) contains 95.1-96.9%
1- benzopyran-6-ol; E307; RRR-a-
v/v (by specific gravity) of C2H6O at
tocopherol; synthetic alpha tocopherol; all-
158C.In the Handbook of Pharmaceutical
rac-a-tocopherol; dla-tocopherol;5,7,8-
Excipients, the term ‗alcohol‘ is used for
trimethyltocol.
either ethanol 95% v/v or ethanol 96% v/v.
Alcohol is a clear, colorless, mobile, and Chemical Name:
volatile liquid with as light, characteristic
(2RS,40RS,80RS)-2,5,7,8- Tetramethyl-2-
odor and burning taste.
(40,80,120-trimethyltridecyl)- 6-chromanol
Typical Properties:
Empirical Formula and Molecular
Antimicrobial activity Ethanol is Weight: C29H50O2; 430.72
bactericidal in aqueous mixtures at
Structural Formula:
concentrations between 60% and 95% v/v;
the optimum concentration is generally
considered to be 70% v/v. antimicrobial
activity is enhanced in the presence of
eidetic acid or edentate salts. Ethanol is
inactivated in the presence of nonionic
surfactants and is ineffective against
bacterial spores. Boiling point 78.158C
Flammability Readily flammable, burning Alpha tocopherol: R1 = R2 = R3 = CH3
with a blue, smokeless flame. Flash point
Beta tocopherol: R1 = R3 = CH3; R2 = H
148C (closed cup). Solubility Miscible with
chloroform, ether, glycerin, and water (with Delta tocopherol: R1 = CH3; R2 = R3 = H
rise of temperature and contraction of
Gamma tocopherol: R1 = R2 = CH3; R3 =
volume). Specific gravity 0.8119-0.8139 at
H
208CNote the above typical properties are
for alcohol (ethanol 95% or96% v/v). Functional Category:
Incompatibilities:
Incompatible with alkalis, heavy metal ions,
especially copper andiron, oxidizing
Functional Category: materials, methenamine, phenylephrine
Antioxidant; therapeutic agent. hydrochloride, pyrilamine maleate,
salicylamide, sodium nitrite, sodium
Applications in Pharmaceutical salicylate, theobromine salicylate, and picot
Formulation or Technology: amide. Additionally, ascorbic acid has been
Ascorbic acid is used as an antioxidant in found to interfere with certain colorimetric
aqueous pharmaceutical formulations at a assays by reducing the intensity of the color
concentration of 0.01-0.1% w/v. Ascorbic produced.
acid has been used to adjust the pH of Safety:
solutions for injection, and as adjutant for Ascorbic acid is an essential part of the
oral liquids. It is also widely used in foods human diet, with 40 mg being the
as an antioxidant. Ascorbic acid has also recommended daily dose in the UK and 60
proven useful as a stabilizing agent in mixed mg in the USA. However, these figures are
micelles containing tetrazepam. controversial, with some advocating doses
Description: of 150 or 250mg daily. Mega doses of 10 g
daily have also been suggested to prevent
Ascorbic acid occurs as a white to light- illness although such large doses are now
yellow colored, non-hygroscopic, odorless, generally considered to be potentially
crystalline powder or colorless crystals with harmful. The body can absorb about 500 mg
a sharp, acidic taste. It gradually darkens in of ascorbic acid daily with any excess
color upon exposure to light. immediately excreted by the kidneys. Large
Stability and Storage Conditions: doses may cause diarrhea or other
gastrointestinal disturbances. Damage to the
In powder form, ascorbic acid is relatively teeth has also been reported. However, no
stable in air. In the absence of oxygen and adverse effects have been reported at the
other oxidizing agents it is also heat stable. levels employed as an antioxidant in foods,
Ascorbic acid is unstable in solution, beverages, and pharmaceuticals.[8]
especially alkaline solution, readily
undergoing oxidation on exposure to the air. SODIUM BENZOATE:
The oxidation process is accelerated by light Synonyms:
and heat and is catalyzed by traces of copper
and iron. Ascorbic acid solutions exhibit
Benzoic acid sodium salt; benzoate of soda; also been used as a tablet lubricant at 2-
E211; natriibenzoas; natriumbenzoicum; 5%w/w concentrations. Solutions of sodium
sobenate; sodiibenzoas; sodium benzoic benzoate have also been administered, orally
acid. or intravenously, in order to determine liver
function.
Chemical Name: Sodium benzoate
Description:
Empirical Formula and Molecular
Sodium benzoate occurs as a white granular
Weight: C7H5NaO2; 144.11
or crystalline, slightly hygroscopic powder.
Structural Formula: It is odorless, or with faint odor of benzoin
and has an unpleasant sweet and saline taste.
-Typical Properties Acidity/alkalinity pH =
8.0 (saturated aqueous solution at 258C). It
is relatively inactive above approximately
pH 5. Antimicrobial activity Sodium
benzoate has both bacteriostatic and
antifungal properties attributed to
undissociated benzoic acid; -
Incompatibilities:
Incompatible with quaternary compounds,
gelatin, ferric salts, calcium salts, and salts
Functional Category: of heavy metals, including silver, lead, and
Antimicrobial preservative; tablet and mercury. Preservative activity may be
capsule lubricant. reduced by interactions with kaolin or
nonionic surfactants. Method of
Applications in Pharmaceutical Manufacture Prepared by the treatment of
Formulation or Technology: benzoic acid with either sodium carbonate or
Sodium benzoate is used primarily as an sodium bicarbonate.
antimicrobial preservative in cosmetics, Safety:
foods, and pharmaceuticals. It is used in
concentrations of 0.02- 0.5% in oral Ingested sodium benzoate is conjugated with
medicines, 0.5% in parenteral products, and glycine in the liver to yield hippuric acid,
0.1-0.5% in cosmetics. The usefulness of which is excreted in the urine. Symptoms of
sodium benzoate as a preservative is limited systemic benzoate toxicity resemble those of
by its effectiveness over a narrow pH range. salicylates. Whereas oral administration of
Sodium benzoate is used in preference to the free-acid form may cause severe gastric
benzoic acid in some circumstances, owing irritation, benzoate salts are well tolerated in
to its greater solubility. However, in some large quantities: e.g., 6g of sodium benzoate
applications it may impart an unpleasant in 200mL of water is administered orally as
flavor to a product. Sodium benzoate has a liver function test. Clinical data have
indicated that sodium benzoate can produce coatings, and to control drug release from
nonimmunological contact urticaria and microcapsules.
nonimmunological immediate contact.[9]
Description:
SODIUM CHLORIDE:
Sodium chloride occurs as a white
Synonyms: crystalline powder or colorless crystals; it
has a saline taste. The crystal lattice is a
Alberger; chlorure de sodium; common salt;
face-centered cubic structure. Solid sodium
hopper salt; natriichloridum; natural halite;
chloride contains no water of crystallization
rock salt; saline; salt; sea salt; table salt.
although, below 08C, salt may crystallize as
Chemical Name: Sodium chloride a dihydrate. -Stability and Storage
Conditions Aqueous sodium chloride
Empirical Formula and Molecular
solutions are stable but may cause the
Weight: NaCl; 58.44
separation of glass particles from certain
Structural Formula: types of glass containers. Aqueous solutions
may be sterilized by autoclaving or
filtration. The solid material is stable and
should be stored in a well-closed container
Incompatibilities:
Aqueous sodium chloride solutions are
corrosive to iron. They also react to form
precipitates with silver, lead, and mercury
Functional Category: salts. Strong oxidizing agents liberate
chlorine from acidified solutions of sodium
Tablet and capsule diluent; tonicity agent. chloride. The solubility of the antimicrobial
Applications in Pharmaceutical preservative methyl parabenis decreased in
Formulation or Technology: aqueous sodium chloride solutions and the
viscosity of carbomer gels and solutions of
Sodium chloride is widely used in a variety hydroxylethylcellulose or hydroxypropyl
of parenteral and nonparental cellulose is reduced by the addition of
pharmaceutical formulations, where the sodium chloride.
primary use is to produce isotonic solutions.
Sodium chloride has been used as a Safety:
lubricant and diluent in capsules and direct Sodium chloride is the most important salt
compression tablet formulations in the past, in the body for maintaining the osmotic
although this practice is no longer common. tension of blood and tissues.[10]
Sodium chloride has also been used as a
channeling agent and as an osmotic agent in
the cores of controlled release tablets. It has SODIUM SULFITE:
been used as aporosity modifier in tablet Synonyms:
Disodium sulfite; exsiccated sodium sulfite; colored powder that would not conform to
E221; natriisulfas anhydrous; sulfurous acid the pharmacopeial specification.
disodium salt.
Typical Properties:
Chemical Name: Sodium sulfite
Acidity/alkalinity pH = 9 for an aqueous
Empirical Formula and Molecular solution. Density 2.633 g/cm3
Weight: Na2SO3; 126.04 Hygroscopicity Hygroscopic. Solubility
Soluble 1 in 3.2 parts of water; soluble in
Structural Formula:
glycerin; practically insoluble in ethanol
(95%). Stability and Storage Conditions
Sodium sulfite should be stored in a well-
closed container in a cool, dry, place.[11]
METHYL PARABEN:
Synonyms:
Aseptoform M; CoSept M; E218; 4-
hydroxybenzoic acid methyl ester; metagin;
Methyl Chemosept;
Functional Category: Antimicrobial methylisparahydroxybenzoas; methyl
preservative; antioxidant. hydroxybenzoate; Methyl Parasept; Nipagin
M; SolbrolM; Tegosept M; Uniphen P-23.
Applications in Pharmaceutical
Formulation or Technology: Chemical Name: Methyl-4-
hydroxybenzoate
Sodium sulfite is used as an antioxidant in
applications similar to those for sodium Empirical Formula and Molecular
metabisulfite. It is also an effective Weight: C8H8O3; 152.15
antimicrobial preservative, particularly Structural Formula:
against fungi at low pH (0.1% w/v of
sodium sulfite is used). Sodium sulfite is
used in cosmetics, food products, and
pharmaceutical applications such as
parenteral formulations, inhalations, oral
formulations, and topical preparations.
Description:
Sodium sulfite occurs as an odorless white
powder or hexagonal prisms. Note that the
commercially available sodium sulfite is
often presented as a white to tan- or pink-
Cosmetic products become easily bathroom, purse, car, or desk drawer is not
contaminated by microbes. Containing an ideal condition natural cosmetic.
water, oils, peptides, and carbohydrates ● Steam, heat, direct sunlight and other
cosmetics are a very good medium for adverse conditions help encourage bacterial
growth of microbes. All these factors growth and most "natural preservatives"
contribute to the fact that cosmetic products can't be used in strong enough
need very good preservation to prevent concentrations to fight contamination
microbial growth and spoiling of the without running the risk of skin irritation or
cosmetic product and also infection of the allergic reactions. Others are useful only
skin. Preservatives are active ingredients against certain strains of contaminants and
able to prevent the growth bacteria, fungi, & for limited amounts of time.
viruses. All our preservatives have potent ● While Vitamin E, Neem and
antimicrobial properties preventing personal Rosemary Oleoresin Extract (ROE) work
care and makeup products effectively from wonders at keeping oils from turning rancid,
spoiling and prolonging substantially the they don't protect against all forms of gram-
shelf-life. Some of these agents also have positive, gram-negative bacteria and yeast
stabilizing effects able to preserve the which are common in unprotected cosmetic
function of various active ingredients products.[16]
including anti-oxidants (vitamins),
emulsifiers and surfactants. The addition of
such kind of stabilizers makes sure that CONCLUSION:
creams, lotions and other complex cosmetic
As we have seen that compared to synthetic
products do not separate or otherwise
preservatives which are used in preserving
disintegrate.[14]
foods, cosmetics, etc., natural preservatives
We should not have to compromise with the have fewer side effects. Natural
quality of our Natural Cosmetics by using preservatives, firstly is a traditional method
harsh preservatives. Use the right of preserving food which have been used for
preservative and adding the right amount to centuries. Natural preservatives have been
the Natural Cosmetics without losing the economical and better availability, so we can
mild and gentle effects of the Natural easily use it.
Ingredients present in the Cosmetics. In
Natural preservatives not only reduce the
order to keep the product safe use of the
bacterial growth but increases the shelf life
right Preservative is needed.[15]
of the ingredient in which it is added. It also
● Many natural substances offer some allows them to remain fresh or maintain its
antibacterial benefits. Certain essential oils, consistency for a long span of time and
like Tea Tree, Thyme and Oregano at high causes no toxic effect. Synthetic
concentrations can be helpful with some preservatives are also good but research has
strains of bacteria. Unfortunately, your reported that they cause many health
problems as almost all are carcinogenic in
nature. Hence these must be used
considering maximum safety limit for the in vitro solubilization of lipophilic drugs; Int
preservatives used in pharmaceuticals as J Pharm; 2001; 222(2); 217-224.
well as cosmetics. Since there are many
4. Constantinides PP et al; Tool emulsions
effective and potential uses of using natural
for drug solubilization and parenteral
preservatives in different ingredients,
delivery; Adv Drug Delivery 2004; 56(9);
satisfactory evidence of its effectiveness and
1243-1255.
safety is still lacking.
5. Hammad MA, Muller BW; Solubility and
The beauty brands that have used natural
stability of tetrazepam in mixed micelles;
preservative systems seem to have done so
Eur J Pharm Sci; 1998; 7(1); 49-55
successfully. However, the challenges going
forward lie in market challenges—lack of 6. Hajratwala BR; Stability of ascorbic acid;
development in the area of new and better STP Pharma; 1985; 1; 281-286
natural preservative systems.
7. Saleh SI, P. Wehrlé, A. Stamm;
―The performance and cost of these systems Improvement of lubrication capacity of
are still not equivalent to the traditional sodium benzoate: effects of milling and
preservatives, so they are not widely used in spray drying; Int J Pharm; 1988; 48(3); 149-
marketed products,‖ 157.
8. Clarke CD, Armstrong NA; Influence of
pH on the adsorption of benzoic acid by
kaolin; Pharm J; 1972; 62(3); 44-45.
Hence, it may better to use natural
9. Leigh S, J carless, B Burt; Compression
preservatives instead of synthetic one, as it
characteristics of some pharmaceutical
provides us so many good effects.
materials; J Pharm Sci; 1967; 56(7); 888-
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