HERBAL FORMULATION
Preparation and Evaluation of Herbal Formulation
(Preparation and Evaluation of Poly herbal syrup)
Herbal
formulations:- Herbal formulation is a dosage form consisting of one or more herbs or
processed herbs in particular quantities to provide specific nutritional, cosmetic benefits and
are
meant to diagnose, treat, alleviate diseases of human beings or animals,
alter the structure or physiology or human beings or animals. Herbal formulations contain a herbal
substance or in combination with one or more herbal preparations. Herbal
formulations are generally obtained by subjecting herbal substances to processes like extraction, distillation, expression, fractionation, purification, concentration or fermentation include comminuted or
powdered.
Herbal formulations comprises of two main components
active constituents and excipients.
Active constituents are responsible for
therapeutic actions to alleviate symptoms, and treat disease conditions.
Excipients are substances formulated alongside the
active ingredients of products, included for the purpose of long-term
stabilization, dose compliance, enablement and control of drug bioavailability, etc. Excipients exist in two main forms; Solid dosage and solutions suspension excipients and may include
sweetening agents, flavoring agents, thickening
agents, diluent, binders, disintegrants and preservatives.
Herbal formulations comprises of
mixtures/decoctions/bitters, extracts,
essential oils, expressed juices, capsules, powders, teas, tinctures, soaps,
ointments, and creams.
TRADITIONAL HERBAL FORMULATIONS:-
A] SYRUPS
Syrups are aqueous
preparations having a sweet taste and a viscous consistency. They contain sucrose having a concentration of at least 65 per cent w/w. The sweet taste can
also be obtained by using other polyols or sweetening agents. Syrups generally
contain aromatic or other flavoring agents. In addition to sucrose, certain
other polyols such as glycerin or sorbitol may be added to slow down crystallization of sucrose or to increase the solubility of added ingredients. Alcohol is added as a
preservative and also acts as a solvent for flavors Antimicrobials are added to resist microbial attack. Syrups having some
added medicinal substances are called as medicated syrup.In dilute solutions, sucrose acts as an excellent nutrient for molds, yeasts and a microorganisms
while in concentrations of 65% by weight or more, the sucrose solution will
slow down the growth of such micro organisms. A saturated solution may lead to
crystallization of a part of the sucrose under conditions of changing
temperature. Sorbitol solution is
the sweetening agent and contains 70% w/w of the total solids, consisting mainly of d-sorbitol. It has about half the
sweetening power of syrup.
Sequestering agents like citric acid or EDTA are used to
minimize the effects of trace metals. Antioxidants are used which delay oxidation by reacting
with the free radicals formed in the product for example propyloctyl and dodecyl esters of Gallic
acid, butylated hydroxyanisole (BHA) and the tocopherol or vitamin E.
Advantages of
syrup:-
1. To mask the taste of
bitter or saline drugs.
2. Has sweet taste so
generally used for pediatric formulations.
3. Has soothing effect
on irritated tissues due to its viscous nature.
Preparation
of syrups:- Syrups are prepared by different method and
the choice of the method
depends upon the physical and chemical properties of
the substances to be dissolved into the syrup.
A]
Solution with heating:
This method is used when the constituent is nonvolatile and heat stable.
The
sucrose is added to the purified water and heated until solution is formed,
then it is strained and sufficient purified water is added to make the desired
weight or volume.
B]
Agitation without heating: This process is used in case of heat labile and volatile
constituents.
Glass-lined tanks with mechanical agitators, especially adapted
for dissolving of sucrose are used
for making syrups in large quantities.
During manufacturing, packaging storage and distribution of
syrups suitable
measures are taken to ensure their microbial quality.
METHOD OF PREPARATION
OF SYRUP:-
A] Method of
preparation of decoction:- Take accurately
weight quantity of herbal powdered as per
given in formula and mixed with 1000
ml of water. Boil the mixture until total volume becomes one
fourth of initial
volume and then cool the decoction & filter it. Use the filtrate to prepare
final herbal
syrup.
B] Method of
preparation of simple syrup:- Mix 66.7% of sucrose in required quantity of distilled
water to prepare a concentrated solution of simple syrup.
C]
Method of preparation of herbal syrup:- Mix one part of decoction with five parts of simple
syrup 1:e (1:5). Add sufficient quantity of methyl paraben as preservative to
the above mixture. Check
the solubility by observing the clarity of solution
visually.
D]
Preservation and Storage:- Syrups should be made in quantities that can be consumed
within few
months except those cases where preservation is done at a low
temperature. Concentration with
supersaturating is also favorable for
preservation. Syrups may contain preservatives glycerin, methyl
paraben,
benzoic acid and sodium benzoate which prevent bacterial and mold growth. Combination of
alkyl esters of p-hydroxy benzoic acidare
effective inhibitors of yeast which have been mixed up in the
contamination of
commercial syrups.
Syrups can be preserved by storing at low temperature
and or by adding preservative such as glycerin,
benzoic acid, sodium benzoate,
methyl paraben or alcohol in the formulation. High sucrose
concentrations will usually protect an oral
liquid dosage form, from growth of microorganism. They
can be stored in dark glass bottles with cork tops
in a cool place for up to 6 months They should be
stored at a temperature not
exceeding 30°c.
EVALUATION OF
POLY - HERBAL SYRUP:- The polyherbal syrup can be
evaluated for
following parameters-
1. Evaluation of
Physico - chemical Parameters:-
A] Organoleptic parameters like
Color, Odor, Taste
B] Determination of pH
C] Determination of
total solids
D] Determination of
specific gravity
E] Determination of
viscosity
2. Phytochemical screening.
3. Quantitative
Estimation of Phyto-constituents like
phenols, flavanoids, alkaloids and
tannins.
4. Quantitative
Estimation of Heavy Metals.
5. Microbial Load
Analysis.
6. HPTLC
finger-printing of the Polyherbal syrup.
7. Acelerated Stability testing of
polyherbal syrup.
A) Organoleptic Parameters:-
Color examination:- Five ml final syrup was taken into watch glasses and
placed against white back
ground in white tube light. It was observed for its
color by naked eye.
Odor examination:- Two ml of final syrup was taken into watch glassesand smelled
individually.
Taste examination:- A pinch of final syrup was taken on tongue and examined
for its taste on taste
buds of the tongue.
B) Determination of PH:- Take 10 ml of the
final syrup in a 100 ml volumetric flask and made up the
volume up to 100 ml
with distilled water. The PH value of a liquid is determined potentiometrically by
means of a glass
electrode or suitable PH meter.
C) Total solid content:- 10 gm of syrup liquid
was taken in evaporated dish which was previously
weighed and allowed to evaporate so that only solid content is
remain in to the dish and rest of the
fluid evaporated. Then it again weighed
and the solid content of syrup is calculated.
D) Determination
of specific gravity:-The
specific gravity of the liquid is a weight of given volume
of the liquid at the
specific temperature compare with the weight of an equal volume of the water at
same temperature.
Procedure:- Take A thoroughly clean and
calibrated dry Pycnometer. The capacity of the Pycnometer
was calculated.
Adjusting the temperature of the final syrup to about 200 degree Centigrade and the
Pycnometer
was filled with it. Then the temperature of the filled Pycnometer was adjusted
to 250 deg
The tare weight of the Pycnometer was
subtracted from the filled weight. The weight per milliliter was
determined by
dividing the weight in air, expressed in g, of the quantity of syrup which
fills the
Pycnometer at the specified temperature, by the capacity expressed in
ml, of the Pycnometer at the
same temperature. Specific gravity of the final
syrup was obtained by dividing the weight of the syrup
contained in the
Pycnometer by the weight of water contained, both determined at 250 deg C.
E) Determination
of viscosity:- Ostwald
viscometer was used to determine the viscosity of polyherbal
syrup. The method
was followed as per the standard procedure.
F) Phytochemical screening:- The phytochemical screening by using different chemical test to check
the
phytoconstituents present in a syrup
like carbohytrates, alkaloids,
glycosides, phenols, flavonoids,
tannins, triterpenoids etc.
G) Quantitative
Estimation of Phytoconstituents:- To estimate the quantity and amount of
phytoconstituents present in a syrup
like Total Phenols, Total Flavanoids, Total Alkaloids, Total
Tannins, Sugar etc.
H) Quantitative
Estimation of Heavy Metals:- Analysis of heavy metals in the syrup such as Total
yeast and moulds count, absence of Escherichia coli, Salmonellae, Clostridia
and Shigella as per WHO
guidelines is checked and quantified by ICP-OES.
I) HPTLC finger-printing of the Polyherbal syrup:- HPTLC is one of the most versatile
chromatographic
methods. It has several advantages like better resolution, faster development
of spots
and also easy detection and quantification of separated compounds. The
time required for the
demonstration of most of the characteristic constituents
of a sample standards are very quick and short.
The fingerprint obtained is
suitable for monitoring the identity and purity of drugs and for detecting
adulteration and substitution in the sample.
J) Stability testing:- Stability testing of
syrup is performed by keeping
the samples at accelerated
temperature conditions. The
final syrup were taken in amber
colored glass bottles and were kept at
accelerated temperature at 40C, Room
temperature and 470C respectively. The samples were tested for
all the
physicochemical parameters, turbidity and homogeneity at the interval of 24 hr,
48 hr and 72 hr
to observe any change.
 Unit - III, PCI syllabus Polyherbal formulation){kind=link}
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