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Medicinus - Dexa Medica

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ples of these are: caryophilli flos, chamomile flowers,<br />

peppermint leaves, etc.<br />

Caryophylli flos, is a drug consist of the dried<br />

buds, dark brown, 12–17 mm long, and has a strongly<br />

aromatic odor, pungently spicy. The drug constituents<br />

are: 15% to more than 20% essential oil with<br />

eugenol as the main component, a little eugenol<br />

acetate, β-caryophyllene and its oxide, α humulene<br />

and its epoxide, flavonoids (quercetin and kaemferol<br />

derivatives), tannins, Gallic acids and sterol glycosides.<br />

5 The drug is used primarily as a spice. The essential<br />

oil has marked antibacterial activity and used<br />

as an antiseptic in dentistry.<br />

Besides these single herbal drugs, a few of which<br />

may also be intended for internal use in powder<br />

form, e.g. cucurbita seeds, ratanhia root, etc., in<br />

practice herbal mixtures also have a major role to<br />

play. These are mixtures which are either prepared<br />

in the pharmacy or industrially, comprising several<br />

drugs often belonging to the same indication group,<br />

to which are added other drugs which assist the action<br />

or are included to correct the taste. It is a good<br />

pharmaceutical rule that herbal mixture should consist<br />

of only a few, about 4–7 drugs. The composition<br />

of herbal mixtures with 20–30 drugs, which are prepared<br />

by a number of manufactures, represents an<br />

attempt at treatment with many drugs below therapeutically<br />

useful levels, which is likely to be of little<br />

help. If the dosage forms consisting of herbal mixtures<br />

is consumed by a patient, the patient would<br />

receive a lot of active substances, each of which has<br />

different pharmacological effects.<br />

The choice of the extraction solvents is an important<br />

factor in finished product quality, and the choice<br />

of drug is pivotal. The drug must first be thoroughly<br />

checked before extraction as far as botanical, phytopathological,<br />

and chemical aspects are concerned.<br />

One needs to consider that plants normally contain<br />

several active substances, and in certain ratio to one<br />

another. Present regulations require that this ratio<br />

be kept, within narrow limits, constant from one<br />

preparation to another, which means starting from<br />

an already standardized raw material. To attain this<br />

objective, if the plant to be extracted is still harvested<br />

in the wild, the area of origin, time of harvesting, the<br />

condition of drying and of storage must be specified,<br />

and in the extraction stage several batches must be<br />

combined to achieve a homogeneous mix.<br />

The extraction of a drug is the separation by<br />

physical or chemical means of a solid or liquid material<br />

from a solid. Normally, when an operation is<br />

performed with solvents for extracting the vegetable<br />

material, it is called solid/liquid extraction. Every<br />

extractive procedure that leads to concentration<br />

equilibrium stops when the distribution of extract-<br />

able substances between solvent and residual drug<br />

is constant. The parameters influencing extraction<br />

are:<br />

1. Swelling of the drug<br />

Pretreatment of the ground drug with solvent<br />

outside the extractor is a rule indispensable, to<br />

avoid sudden swelling of the drug, to ensure<br />

uniform moistening at the material, and to increase<br />

the porosity of the cell wall.<br />

2. Diffusion, pH, particle size and temperature<br />

For the extraction of a substance from vegetable<br />

material the solvent must diffuse into the cell<br />

and in its turn the substance must be sufficiently<br />

soluble in the solvent. Equilibrium will be established<br />

between solute and solvent, the speed<br />

of with which it is attained depending on temperature,<br />

pH, and particle size.<br />

3. Choice of extraction solvent<br />

The ideal solvent is obviously one of that presenting<br />

maximum selectivity, has the best capacity<br />

for extraction in terms of coefficiency of<br />

saturation of the product in the medium and<br />

is compatible with the properties of the material<br />

to be extracted. Ethyl alcohol is the solvent<br />

of choice according to the pharmacopeias for<br />

obtaining classic extracts such as soft, fluid and<br />

dry extracts still widely used in pharmaceutical<br />

formulations. As these solvents have a great extractive<br />

power, the ideal alcohol/water ratio for<br />

the extraction of plants woody parts or barks,<br />

roots and seeds is about 7:3 or 8:2, whereas it<br />

must be lower than 1:1 for extracting leaves or<br />

aerial green parts. With an alcohol/water ratio of<br />

1:1 it is possible to avoid the extraction of chlorophyll,<br />

or resinous or polymeric substances that<br />

are normally of no importance to the activity of<br />

the extract but that greatly complicate the subsequent<br />

stage of concentration by giving rise to<br />

gummy precipitates that are hard to eliminate,<br />

and push serious problems of phytopharmaceutical<br />

formulation.<br />

PHYTOPHARMACEUTICAL FORMULATION<br />

technology<br />

The formulation of phytopharmaceutical raw material<br />

into dosage forms is a complex operation which<br />

cannot be regarded only as a problem of pharmaceutical<br />

technology. It is more demanding in that it<br />

calls for close collaboration between manufacturer<br />

and formulator especially of extract based products.<br />

The problem of controlling extract has two aspects;<br />

those are pharmaceutical technology and phytochemical<br />

aspects.<br />

The types of tests to be done on an extract are<br />

essentially three: for the determination of the physi-<br />

MEDICINUS 24(1), January 2011 37

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