Belladonna
Dry Extract is a dried and powdered, alcoholic percolate of Belladonna Herb, adjusted
to contain not less than 1.15% and not more than 1.25% of the alkaloids of Belladonna
Herb, Calculated as Hyocyamine.
A
Greenish brown powder with characteristic odour,
Solubility
Insoluble
in water, alcohol and other solvents.
Identification
Give
positive tests for the presence of alkaloids with mayer's reagent & Dagendorff's
reagents.
Loss
on drying
Not
more than 5.0%
Heavy
Metal
(Pb
less than 10 ppm)
E.Coli(cfu/gm)
Negative
Salmonella(cfu/gm)
Negative
Assay
Not
Less than 1.25% .
(Calculated on the basis of Hyoscyamine)
2. Specification
of Belladonna Soft Ext.
Product
BELLADONNA
SOFT EXT. (MinT.A.1.5%)
Description
Belladonna
soft Extract is a soft alcoholic percolate of Beladonna Herb, adjusted to contain
not less than 1.5%. as Hyocyamine.
A
Greenish brown extract with characteristic odour,
Identification
Give
positive tests for the presence of alkaloids with mayer's reagent & Dagendorff's
reagents.
Loss
on drying
Not
more than 25.0%
Heavy
Metal
Not
more than 0.001%
Assay
Not
Less than 1.5%
(Calculated
on the basis of Hyoscyamine)
3. Specification
of Total Alkaloids of Belladonna
Product
TOTAL
ALKALOIDS OF BELLADONNA.
Description
Colourless
crystalline, odourless powder taste very bitter.
Solubility
Freely
soluble in alcohol and in chloroform
Identification
A)
Complies.
B)
Positive to Alkaloids test.
Specific
Rotation
Between
-23 to -25.
Melting
Range
Between
110-115.
Residue on Ignition
Not
more than 0.2%
Sulphated Ash
Not
More than 0.1%
Loss
on drying
Not
more than 1.0%
Assay
Not
less than 98% (Calculated on the basis of Hyoscyamine)
Description
of Belladonna.
[BEAUTIFUL
LADY.]
Part Used.-The
root, and the mature leaves of Atropa Belladonna, Linn.
Common
Names.-Deadly Nightshade, Dwale, Black Cherry, Strygium, Strychnon. According
to Matthiolus of old, the Venetians called it " Herba Belladonna," because their
ladies used a distilled water of the plant as a cosmetic; hence the name, " Bella-donna"
(Beautiful Lady).
Description,-Green
Belladonna root is from one to two inches thick, and a foot or more in length.
The root is brown, rough, marked by transverse ridges, and by stout, divergroots.
It has a radiate structure if sliced tranversely ; is possessed of an earthy smell,
has little taste, but leaves a powerful,acrid after-taste. The bark is thick,
juicy, and internally of a dull cream color, The dried root is rough, dirty-grey
externally, whitish internally, appearing in commerce in irregular pieces, (See
cut No. 1, showing good root; No. 2, inferior, sliced old root.) So far as medicinal
value is concerned, the bark is the richest part of the root, hence (see cut No.
J and also Drug Study No IX, page 5, Gelsemium), small roots are desirable, because
in them the proportion of bark is greater, Until now, all the Belladonna root
of commerce has been the wild drug of Germany. Cultivation on a large scale by
Johnson & Johnson have been exceedingly promising, especially as concerns its
quality. If it becomes an American crop, culture will permit of its collection
when in best condition.
No-:
1
No-:2
The
microscopic structure of Belladonna is peculiar, in that many of the cells of
the middle layer, as well as central parts of the root, are loaded with small
No, octahedral crystals of calcium. The following data from " Red Cross Notes,"
Series V, No. 2, Johnson & Johnson, records the yield of total alkaloid, at different
dates, in cultivated Belladonna: Seeds planted in hot houses in February and March,
1904, transplanted to the open field in May. June 24th. Plants, 6 inches high.
A u g u s t 13th Fruit Setting. Leaves, 0.453. Leaves, 0.375. Roots, 9.568. Roots,
0.27. July 28th. Plants in full bloom. September 26th. . End of Season. Leaves,
0.5 143. Leaves, 0.800. Roots, 0.337. Roots,
Constituents.-In
Apply to
the Belladonna our opinion, the term derivatives wi 11 better ultimate, than constituents.
Even the best known alkaloid derived from it (atropine) d o e s not exist materially
in prime Belladonna. But yet the drug tissue of all parts of Belladonna is strongly
alkaloidal, and inasmuch as one of the final products of corruptive chemistry
is the characteristic a l k a l o i d atropine, this strongly personal substance
is usually taken as a standard for e s t i m a t i n g t h e d r u g . Atropine
was discovered in Belladonna root in 1819 by Brandes and was made in pure form,
1833 (Fluckiger),by a German apothecary named Mein, and was almost simultaneously
discovered in the herb by Geigerand Hesse. The root is exclusively employed by
alkaloid manufacturers (see Scopolia, p. 5), but it varies greatly in alkaloidal
yielding qualities. Considered from this point of view, Belladonna is one of the
drugs needing most watchful care. Lefort (1872) showed that the maximum of atropine
yielded by young roots was 0.6 per cent, whilst old, large roots gave not more
than 0.25 to 0.31 per cent. In our experience it is not easy to find commercial
Belladonna to assay as high as 0.5 per cent pure, total alkaloid.
Belladonna
root and leaves yield other alkaloids and other constituents than atropine. These
are subjects of much controversy, because experimenters, by reason of different
methods of procedure, have either failed to find what others have discovered,
or by their chemistry have created substances others did not produce. Some of
these products may be named as follows:
USES OF
BELLADONNA
Uses
based on scientific evidence Grade*Irritable bowel syndrome
Belladonna
has been used historically for the treatment of irritable bowel, and in theory
its mechanism of action should be effective for some of the symptoms. However,
of the few studies that are available, none clearly show that belladonna alone
(not as part of a mixed product) provides this effect.
Airway
obstruction
Belladonna
can cause relaxation of the airway and reduce the amount of mucus produced. A
study in infants demonstrated possible beneficial effects of belladonna on airway
obstruction during sleep. However, due to lack of high-quality human research
in this area, there is not enough evidence to form a clear conclusion.
Nervous
system disorders
The
autonomic nervous system, which helps control basic body functions like sweating
and blood flow, is affected in several disorders. To date, human studies have
shown no benefit from belladonna in treating these disorders.
Headache
The
available studies of belladonna in the treatment of headache are not well designed
and do not show a clear benefit. More studies are needed to test the ability of
belladonna alone (not in multi-ingredient products) to treat or prevent headache.
Ear infection
Little
reliable research is available on the use of belladonna for ear infections. Other
therapies have been shown effective and are recommended for this condition.
Premenstrual
syndrome (PMS)
Bellergal®
(a combination of phenobarbital, ergot, and belladonna) has been used historically
to treat PMS symptoms. Limited study in women reports improvement in symptoms.
More studies are needed before a strong recommendation can be made.
Radiation
therapy rash (radiation burn)
There
is a lack of reliable scientific evidence available for the effectiveness of belladonna
for rash after radiation therapy. Further study is needed before a recommendation
can be made.
Menopausal
symptoms
Bellergal®
(a combination of phenobarbital, ergot, and belladonna) has been used historically
to treat hot flashes. However, in human studies belladonna supplements have not
shown effectiveness.
Dose and
Fatal Period. -W h e n atropine is the poisonous agent
the effects are much quicker than with Belladonna, and abolition of muscular power
may occur without either delirium or convulsions having occurred. A few Belladonna
berries have caused death, as has an enema containing 1-6 grain of atropine. By
mouth 1-12 grain of atropine and hypodermically 1-30 grain have likewise proved
fatal., Again, recovery has followed the injection of much larger doses. Death
has occurred in five minutes after the injection of atropine. It seldom takes
place in less than two hours, and usually does not occur under fifteen to eighteen
hours. Symptoms of poisoning are often delayed from one hour to five hours after
taking the drug.
Treatmentof Belladonna poisoning should be prompt. Emetics, stomach
pump, lavage tube, and tickling the throat to produce emesis should be resorted
to at once. As Belladonna tends to wholly suppress the urine, catherization should
be resorted to early and frequent, to eliminate the poison and to prevent its
reabsorption. As emetics, zinc sulphate, 20 grains, powdered ipecac, IO grains,
or mustard and salt (equal parts), 2 teaspoonfuls may be given in warm water,
followed by copious draughts of luke warm water, to facilitate emesis. Unless
contraindicated by marked depression, B grain of apomorphine may be given. Purgatives,
such as castor oil, are useful to free the intestinal tract of the poison. Sweet
spirit of nitre facilitates its removal by way of the urinary organs.
As partial
chemical antidotes, animal charcoal, tannic acid, and solution of iodine may serve
a useful purpose. While by no means a settled fact that morphine and Belladonna
are in all respects antagonistic, it is still recognized that morphine judiciously
employed is the best antidote to Belladonna and atropine poisoning. The best rule
to follow is to be guided by the papillary response. Therefore small and repeated
doses administered until the pupils contract and are maintained in contraction
is the best method to pursue. From the fact that jaborandi and its alkaloid pilocarpine,
and calabar bean and its alkaloid physostigmine are in some measure antagonistic
to Belladonna, they have been recommended and employed as physiological antidotes
in poisoning by atropine and Belladonna.
PHARMACEUTICAL
PREPARATIONS.
Fluid
and Solid Extracts, U. S. P.-The solid extract is made from
Belladonna leaves, the fluid extract from Belladonna root. These are the official,
pharmacopoeial preparations. When properly prepared they are very energetic, but
are open to the general objection to extracts, in that the large amount of inert
extractive materials present, is often a disturber of both quality and elegance.
Still,
inasmuch as no one constituent obtained from the drug parallels the natural combination
in a safely therapeutic sense, physicians of the Regular School in medicine very
wisely maintain these extracts as their remedial Belladonna standards. The solid
extract, properly made, be it stated, stands unexcelled as a constituent for plasters,
and as a component for Belladonna ointments.
Tincture
of Belladonna, U. S. P., is made of Belladonna leaves. It
has no advantage over the fluid extract, and seer & to us to be one of the preparations
the U. S. P. Revision Committee might well drop.
Belladonna
Plaster.-This is made (U. S. P.) by incorporating extract
of Belladonna with an excipient made of a mixture of soap plaster and resin plaster.
It is a great favorite with physicians and is a deservedly popular preparation.
It should by assay produce 0.5 per cent mixed alkaloids of Belladonna root. In
this connection the United States Dispensatory observes that " machine-spread
Belladonna plaster can be found on the market, which was admitted by a representative
of the manufacturer, to contain no Belladonna whatever." Whether such trade plasters
are made of Scopolia, or the alkaloids, matters little, they are not true to name.
The "rubber" machine plasters are very elegant and very satisfactory, and our
experience with Mr. Kilmer during many years has convinced us that in his direction
at least the most exacting pains are taken with the extract, which is unquestionably
true to name.
Specific
Medicine Belladonna.- This preparation is the recognized
standard with Eclectic physicians. The process of preparation abstracts the characteristic
structural drug constituents, without any application of chemistry or the use
of chemicals, the aim being to correlate the qualities of the drug as a whole,
and preserve them in an imperishable form. To this effect, continuous systematic
investigations have been applied for several decades. The standard of strength
is that of one grain of the best drug to one minim of the finished product. The
concentration is accomplished by means of apparatus that attains the desired object,
without disintegrating the natural drug constituents. (*) Specific Medicine Belladonna
has established itself as a standard of excellence, and has maintained this position
for thirty years. It is not, however, commended nor employed because it contains
atropine, for as Belladonna root does not appreciably contain atropine, the Specific
Medicine Belladonna, carrying the unaltered constituents of the root, is practically
free from the alkaloid. If, however, it be assayed by the usual methods adopted
with Belladonna liquids it will, by reason of the chemistry applied, yield the
Belladonna alkaloids liberally. Solutions of atropine and its salts are easily
made (see atropine), they are physiologically very active poisons, and if the
alkaloid only is wanted, preparations labeled Belladonna can be readily (and very
cheaply) made to stand atropine tests, wi t h o u t the use of any Belladonna
drug whatever.
Qualities.-Our
experience teaches that to carry the full structural value of the Belladonna constituents
into the Specific Medicine Belladonna necessitates the inclusion of the dark-colored
semi-resin, between which and the structurally active compound exists a very intricate
relationship. It is a part of the active tissue of Belladonna, and we accept that
the markedly characteristic and yet lasting action of the Specific Medicine is
largely due to the qualities that reside in the complex structure, in which this
relative of resins takes an undetermined, but yet very important part. Consequently,
Specific Medicine Belladonna is an exceptionally dark-colored member of the class
of preparations (Specific Medicines) which are, as a rule, very light in color.
It possesses a slightly sweet odor, and an insipid, but not unpleasant taste,
which, however, leaves a long, lingering, acrid after-taste, and a persistent,
dry sensation in the throat. Added drop by drop to alcohol, a red-brown color
is imparted, the liquid remaining clear. Water, under the same conditions, becomes
dark and semi-opaque. The gradual addition of ammonia water scarcely affects the
color of the alcoholic solution, but it instantly clarifies the aqueous mixture,
producing a brilliant, red-brown liquid.
THE THERAPEUTICS OF BELLADONNA.
Belladonna
is a remedy deserving the 'most intimate consideration of the up-to-date therapeutist.
It is not necessary that I contrive a scheme in mind, in order to substantiate
the assertion that many medical men of to-day know comparatively lit tle concerning
the positive medicinal qualities of Belladonna, and less concerning when and how
it should be exhibited in order to obtain its real value as a medicine. None of
us know it all, but there are too many who do not understand the remedy as they
should.
There
can be no doubting the fact that the promiscuous prescribing of remedies is incorrect;
and by that I mean the practice of prescribing medicines irrespective of real
pathological conditions, and that of exhibiting them because some one recommended
that they be employed in this or that disease, is no good practice and far from
correct.
The
laity in general understand that Belladonna is an energetic, narcotic poison,
if taken in excessive and inordinate doses;-it is to be noted, and a fact attractive
of particular attention; that the doses recommended by many medical men are, if
therapeutic effects are desired, exceedingly excessive; for it certainly is one
thing to get the physiological effect of a drug, and another to obtain its therapeutic
result. And it is also a fact that drugs known to be active poisons may prove
to be among our best medicines.
Belladonna
kills by exhausting the powers upon which circulation and respiration depend-
it paralyzes cerebro-spinal centers probably more by its primary effect upon the
sympathetic, than by its direct effect. Before its paralyzing influence is exerted,
its effect as a circulatory and a cerebral excitant is particularly noticeable,
cerebral disturbances being exceedingly prominent. Large doses paralyze, small
doses stimulate, and it is through its action upon the nervous system that its
circulatory effect is obtained. It is said of Belladonna that if given in continued
large enough doses to dilate the pupils, its usefulness as a remedy is lost, in
so far as concerns its specific action. To be able at all times to exhibit the
remedy in such manner and doses as will best exhibit its specific action, is of
far more importance to the therapeutist, than it is to administer it merely to
the extent of receiving its physiological effect, and then discontinue its use.
Whilst it is true that the physiological effect of a drug is sometimes desirable,
it is equally true that the therapeutic, or rather specific action of a remedy
is usually what we are interested in. The specific action can best be obtained
by the careful observation of pathological conditions which have been known to
be relieved by the remedy, the size of the dose, and the employment of a reliable
preparation of the drug. On account of the uniformity of strength, it has been
our custom to use the Specific Medicine Belladonna, and at this time we entertain
not the least desire to discontinue its use. Thousands of physicians highly esteem
that preparation of the drug, and employ it exclusively.
It
may be well to advise those unfamiliar with the Specific Medicine Belladonna,
that if large doses of the drug must be administered, and specific action is desirable,
this preparation of the remedy had best be let alone, for, owing to its energy,
results will not be satisfactory, and the preparation will be wrongfully condemned.
When dosage is mentioned throughout the following paper, it applies only to the
Specific Medicine. The direct specific indication for Belladonna is impairment
of the capillary circulation, with congestion. With this condition always before
us, not much difficulty will be experienced to find its exact place in therapeutics.
In acute disorders, where there is inclination to dullness or stupor, or where
these conditions really exist, pupils dilated, face pallid and expressionless,
cerebral congestion, sluggish capillary circulation, extremities cool-all these
call for Belladonna, but in small doses. It stimulates capillary circulation by
its decided influence upon the vaso-motor centers and nerve peripheries; is a
direct and powerful stimulant to the sympathetic and the heart, exercising a powerful
influence in enfeebled heart's action and depression of the sympathetic influence.
Whether child or adult, if during the course of disease our patient shows a decided
disposition to sleep, there is dullness of intellect, dilated pupils, oppressed
pulse, eyes partially open, all indicative of cerebral congestion, Belladonna
is indicated. There is a condition of chilliness, skin pallid, pulse full but
oppressed, dull, sleepy headache, indicating capilliary stasis, which Belladonna
overcomes. Those dull, heavy headaches, where pain is constant and where there
is a feeling that if it were not for the pain, the patient could sleep, the remedy
promptly relieves.
In
cerebral or spinal congestion, acute or chronic, where there is a dull, heavy
aching and fullness in the head, drowsiness, eyes dull, pupils dilated, or a condition
of apparently threatening apoplexy, Belladonna is a positive remedy. Sore throat,
where the mucous membranes have a dark-red, dusky color, capillary engorgement
plainly evidenced; at the onset of or threatened inflammatory conditions, pneumonitis
for instance, to relieve the capillary engorgement and prevent local effects,
the remedy is indicated. Persistent inclination to sleep, accompanied by vomiting,
is relieved by it. So is whooping cough, where there is also the characteristic
dullness, hebetude, and impairment of capillary circulation. In the exanthemata,
especially the congestive forms, scarlatina in particular, eruptions are tardy,
the skin appears congested and patient is drowsy, the remedy proves of true value.
In meningeal inflammations, especially in the subacute forms, temperature several
degrees above normal, skin cold and moist, eyes dull, pupils dilated, head drawn
back, and is being rolled from side to side, eyes partly open during sleep, the
remedy is directly indicated. Post-scarlatinal nephritis is a frequent condition
relieved by Belladonna; so are other cases of renal capillary engorgements. In
all of the foregoing conditions the remedy proves its best results when given
in small doses; from five to eight drops are added to four ounces of water, and
this solution is given in teaspoonful doses every hour, or every two hours. The
condition commonly called diabetes insipidus, where extremities are cold and there
is feebleness of the sympathetic, and incontinence of urine, when there is relaxed
tissues and an engorged circulation, Belladonna will cure, but the dose usually
is larger- say one-third to one-half drop doses, in children not so much. Its
value in nightsweats is unquestionable, and to arrest secretion of the mammary
gland its action is prompt. I have seen exanthematous eruptions follow the administration
of small doses of the drug; these were similar to the eruptions of scar- latina,
and disappeared promptly with the withdrawal of the drug. And I have seen cases
whee usual conditions calling for Belladonna where present, but the pupils were
contracted; still, the agent seemed to exercise its usual beneficial effect. Neuralgic
conditions, neuralgic dysmenorrhoea, where cool extremities and chilly sensations
are marked, will be promptly relieved by the remedy, the dose being somewhat larger.
I believe it to be a prophylactic against scarlet fever, if given in small doses;
and if administered early in that disease, the eruptions will more readily appear
and renal congestion will be avoided.
I
believe Belladonna to be particularly a child's remedy, and know that the dose
must be small, if beneficial results are to be obtained. Active delirium during
fevers, where there is cerebral congestion and surface circulation is markedly
sluggish, dusky appearance of skin, will be subdued if the remedy is given in
grain doses of the 3x. Deep aching of loins or back, with a sense of heavy fullness,
will be relieved by one-third drop doses; so will the aching and chilliness often
present during a "cold" or preceding fever or grippe. In constipation, when the
sphincter ani is abnormally contracted and there is local capillary congestion
and lack of secretion, Belladonna is indicated. In " run-down " individuals, where
there is indisposition to exertion, extremities are cold, nervous debility, when
it is desirable to stimulate, this agent alone, or combined with any other indicated
remedy, will produce salutary effects. Belladonna has proven valuable in other
conditions farther than those mentioned. Salivary overactivity can be controlled
by it; epilepsy or epileptiform convulsions, when congestion exists, are benefited
by its use; it is known to cure certain cases of rhus poisoning and erysipelas;
mastitis and orchitis are relieved; as an antidote to opium it is well known,
and its influence in particular eye affections is pronounced. In eye affections,
however, we do not usually depend upon the internal administration of Belladonna
for results.
Owing
to its special adaptability in ophthalmic work, it is customary to exhibit sulphate
of atropine, a poisonous alkaloid obtained from Belladonna, and even in the eye,
particular care must be exercised in using the alkaloid, in order to avoid doing
mischief or irreparable harm, The cases in which atropine is applicable should
be selected according to conditions, and these distinguishing points are made
clear to us in works devoted to this particular kind of affections. I have said
that the direct indication for Belladonna is impairment of the capillary circulation,
with congestion. Feeble innerva-tion, feeble and sluggish circulation with tendency
to drowsiness or coma, dilated pupils, cool extremities, describe it pretty well.
Now it matters not whether it is the skin, spinal cord, cerebral, cerebrospinal
centers, or where or by what name the disease present has been called; if such
conditions as I have mentioned are present, Belladonna is the remedy. It will
relieve the array of conditions above mentioned, which we recognize by nature's
evident display of distress. But the dose of the remedy must be in the proportion
as taught us by experience; small doses must be used if its specific effect is
desired,
SPECIFIC
INDICATIONS AND USES.
This
the remedy for congestion, especially of the cerebro-spinal centers. The indications
are: dull eyes, dilated pupils and somnolence or coma. The symptoms calling for
the use of Belladonna are usually very plain: the patient is dull and stupid,
and the child drowsy, and sleeps with its eyes partly open; the countenance expressionless
; the eyes are dull and the pupils dilated or immobile; whilst as it continues
respiration becomes affected, and the blood imperfectly aerated.
Belladonna
is the remedy for urinary affections, particularly for children, especially when
associated with capillary inactivity and a tendency to congestion, throbbing pain
in the region of the kidney, and urinal incontinence are conditions in which it
proclaims its power. It overcomes spasms of the body orifices. Some forms of whooping
cough are relieved by Belladonna, and it is an all important remedy in the exanthemata
and in the sore throat of a dry, deep red and swollen character, with great difficulty
in swallowing. Mental hebetude and the dull expressionless countenance are very
clear indications for Belladonna.
Use.-In
congestion of the brain and spinal cord ; in congestive disease of any part; in
scarlet fever, and i n some cases of whooping cough and sore throat.
Dosage.--Rx
Belladonna, gtt. v to gtt. x; Water, 3iv. M. Sig.-A teaspoonful of the dilution
every hour, Poisonous in overdoses.