Note: Descriptions are shown in the official language in which they were submitted.
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1 PREPARATION FOR REH~DRATING MONOGASTRIC ANIMALS,
INCLUDING HUMAN BEINGS, SUFFERING FROM DIARRHOEA
AND USE THEREOF
The invention relates to a preparation for rehydra-
ting monogastric animals, including human beings,
suffering from diarrhoea, especially non-infectious
diarrhoea and diarrhoea caused by rota and corona
viruses.
Even in well-organized agricultural countries with
good veterinary coverage, the mortality among new
-born animals such as calves and pigs is still very
great. For example, in Denmark in 1980 there were
destroyed about 180,000 calves, which corresponds to
nearly 20% Or the calves born every year. The cause
of a number of the deaths among calves, and also of
a number of corresponding deaths among sucking pigs,
is that they become stressed when they are weaned and
placed, for example, in common sties or folds. When
~- the animals are removed and thus no longer receive
J''~ mother's milk, ~g~ up to half of the animals devel-
.~
op diarrhoea because they become stressed due to
change of fodder, transportation etc. It is assumed
that half of the deaths are due to diarrhoea which
arises within the first month after their birth. A
number of the calves also suffer from rota and corona
virus infection, which is a contagious intestinal
infection where cows are virus carriers and infect
the calves. The disease is caused by ia. strongly
reduced production of lactase, so that the animals
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cannot decompose the ~ ~6~ in the milk with which
they are fed, and hereafter diarrhoea is quickly
developed by osmotic effect in the intestinal canal.
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New-born calves and pigs with diarrhoea will lose con-
side.rable weight because of dehydration and many die.
An object of the invention is to present a prepara-tion for
the treatment of diarrhoea, so that a very large number of
sick animals can be cured in very few days, whereby deaths
due to loss of fluid is avoided and for calves better growth
is obtained.
According to the invention there is provided a preparation
for rehydrating monogastric animals, including human beings,
suffering from diarrhoea which preparation is of the kind
containing electrolytes and glucose. The preparation consists
oE (a) 20-70% by weight of an absorbent intumeseent con-
sisting of Isphagula Husk; (b) 40-60% by weigh-t of eleetro-
lytes whieh eleetrolytes are a mixture of two or more of the
substances magnesium oxide, magnesium carbonate hydroxide,
magnesium hydroxide, magnesium silieate, calcium silicate,
ealeium earbonate, alkali metal chlorides, ineludi.ng sodium
and potassium chloride, alkali metal hydrogen carbonates,
including sodium and potassium hydrogen earbonate, aluminium
phosphate, aluminium hydroxide, citric acid and alkali metal
citrates, including sodium and potassium eitrate, and in ad-
dition to the eleetroytes glucose; (e) 0.01-5% by weight lac-
tase and in that said preparation optionally consists also of
roughage, pectin, starch, one or more taste correetives
and/or one or more colouring agents, wherein -the amounts of
the individual components are ehosen in a way so that the sum
total of the pereentages by weight of -the components is
100.00.
Surprisingly, it has been shown that a mixture of an
absorbent intumescent agent, lactose-decomposing enzymes and
one or more electrolytes is a quiek and effeetive agent
against diarrhoea without any apparent side effeets and with
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- 2a -
a better effect than with the :individual components alone.
The agen-t can be used for the treatment of diarrhoea among
all offspring of ruminan-ts as long as these are one-
stomached, ie. before they have begun cud-chewing, and for
the treatment of non-infectious diarrhoea and diarrhoea
caused by rota and corona viruses among all other one-
stomached animals, including human beings. The lactose-
decomposing enæyme decomposes the lactose which, for example,
a calf suffering from diarrhoea is itself unable to decompose
and digest. Non-decomposed lactose in the intestinal canal
con-tributes to worsening an attack of diarrhoea. With
certain other methods of treatment, it has been suggested
that the lactose be decomposed in the milk before the calf
receives the milk, but with the preparation according to the
invention, the lactose is not decomposed until inside
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1 the calf's stomach and intestine which results in
fewer side effects, for example in the form of
sitiophobia.
The agent is produced quite simply by wei~hing out
and mixing the individual parts so that the finished
agent is supplied as a dry powder ready for use.
Another great advantage of the preparation according
to the invention is that it is possible to cure
animals of diarrhoea without the use of normal anti-
biotics, and thus avoiding the disadvantages here-
with in the form of medicinal residues in the animal,
and the possibilities of developing bacteria strains
resistant to antibiotics.
According to the invention it is very advantageous
that the electrolytes in the preparation comprise
such salts that replace salt lost by diarrhoea since
by rehydration it is merely necessary to administer
a preparation which will bring about both rehydration
or stop dehydration and pro~dethe lost salts and
~luid.
25 When the preparation comprises a buffer, it is
not necessary to protect the enzymes by adopting
special measures since the preparation
itself for a period of up to 6 hours stabilises the
pH-value of the stomach so that the enzymes are not
inactivated, and it is not necessary to wait for the
dissolution o~ a coating or the like in the intestine~
the enzyme being immediately ready to perrorm its
function. Thus protective measures for the enzyme are
alsc spared.
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1 The component parts must be such which are pharmaceu-
tically tolerable and a combination of the parts men-
tioned in claim 4 makes it possible to fulrill the
purpose of the present invention.
By composing the preparation as disclosed in claim 5
there is obtained a simple preparation which has the
required properties, ie. stopping diarrhoea, provid-
ing the necessary salts, providing lactase and bring
ing it uninfluenced through the stomach in a simple
manner.
It is an advantage that the absorbent vegetable fibres
swell up in the intestine in a very suitable and natural
manner, which gives the contents of the inte~tine a
gelatinous consistency so that the ~aeces will have
a normal consistency already a ~ew hours after the
first feeding with the agent. The more quickly that a
diarrhoea rrom which a cal~ or sucking pig is su~fer-
ing is brought under control, the greater are thechances of the animal surviving. The glucose content
and the necessary salts in the correct amounts will
promote the absorption of nutrients and give the
weakened animal an easily transformable energy.
Practical applications and experiments have shown
that the agent according to the invention is par-
ticularly effective when the sphagula Husk has
been ground.
.
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1 If this agent is used immediately when an animal
shows the symptoms of diarrhoea, and it is a question
of so-called problem stock, then the agent according
to the invention should be used in the event of the
animal merely refusing to drink up, and a case of
diarrhoea can normally be stopped merely by treating
the animal a few times. It is thus possible to put
an immediate stop to the life-threatening loss of
water and salts (electrolytes) so that by far the
10 majority of the animals attackecl will survive and
be restored to health quicker than if they are only
treated with electrolytes alone or the water
palliative fibres alone. This quicker restoration
of the animals will therefore bring about a better
15 growth which has been proved by clinical experiments.
By composing the preparation witnin the specific weight
ratios as disclosed in claim 7, there is obtained a
preparation which will stop diarrhoea among animals and
20 provide rehydration since the preparation will only have
to be mixed in water or milk or a water/milk mixture
whereupon an animal will willingly drink it.
25 For human application with the specific weight range
the pxeparation is composed without roughage and dyestuffs
but with a corrective having the composition mentioned in
claim 8, a composition within specific weight ratios as
disclosed in claim 9 being particularly preferred since
30 such a preparation is effective and at the same time has
a pleasant taste.
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1 The preparation according to the invention as dis~
closed is used by pouring 40-55 g of the
mixture into lukewarm water, milk or a water/milk
mixture at around 38C. q~e result is a mixture which
the animals are very willing to drink and which
quickly cures them of diarrhoea because the gel ~orm-
ed by the agent in the intestinal canal has the ~ol-
lowing characteristics:
~,) a protective ef~ect on the actual intest-
inal mucosa,
b) binds some of the bacteria and their
toxins to itselr,
c) ensures a normal intestinal passage
(peristalsis),
d) quickly stops the loss of fluid and
electrolytes,
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1 e) buffers the capacity due to the added
electrolytes in the gel formed, protects
the added lactase from inactivation for
up to 6 hours, and
f) the lactase decomposes the lactose in the
intestine and thus recreates a normal
osmotic balance.
For human application the same results as mentioned
above will be obtained. If desired, cold liquid can
be used for the preparation.
Practical experiment with the preparation according
to khe invention.
480 sucking calves, all of them two to three weeks
old, were taken in for rearing experiments under
uniform optir~um conditions with regard to hygiene,
climate and feeding, the object being to test the
effect of the preparation on dietetic-conditioned
diarrhoea among sucking calves.
By the first feeding after the calves taken in had
been placed in the cow-house at the research station,
all of the calves each received three litres of a
conventional electrolyte/water mixture, after which
this was gradually changed during the course of five
days to up to 7 litres of milk substitute. ~he calves
also had free access to hay and ordinary fodder
supplements.
During the course of fourteen days from the time they
were taken in, 86 of the calves, ie. 17.9%, contract-
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1259913
1 ed stomach/intestinal disturhances. These animals
were immediately ~reated with the preparation accord-
ing to the invention and as disclosed in claim 12.
5 73 of the sick calves, ie. 84.9%, were completely
cured within a few days. The 13 calves which were
not cured immediately by the treatment were then
given supplementary treatment with antibiotics~
10 From this it will be seen that the diarrhoea which
is contracted early by many calves fattened on full
milk and by sucking pigs is often due to virus
infections and to transport stress, stress as a
result of feeding change and stress from changed
15 environment etc., and can therefore be cured with the
preparation according to the invention without the
use of antibiotics. O~ly 13 animals out of 86, ie.
approx. 15%, required supplementary antibiotic treat-
ment.
Course of treatment when using the preparation.
The agent is mixed in water and is dosed in accord-
ance with the weight of the animal, the amounts used
25 being as stated in the following table:
Weight of Dose perNo. of feeds
animal feedingper 24 hours
approx. 20 kg~ l water + approx. 25g 4
30 - 30 kg 1 l - + approx. 50g4
- 40 kg 1~ 1 - + approx. 75g 3-4
- 50 kg 2 l - + approx. lOOg 3
- 60 kg 2~ 1 - + approx. 125g 3
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1 After the first twenty-four hours, lt can be an ad-
vantage to add 25-50 g curdled milk product, ~or
example soured milk, yoghurt, junket or the like,
per litre. From the third day, one can gradually
change over to the normal mixed fodder.
There are also cattle stock among which stomach/
intestine dlsturbances are a recurrent problem. In
such cases lt can be an advantage to glve for example
the calves the preparation according to the lnvention
as soon as they just refuse to drlnk up the normal
feed, for example consisting of full-cream milk or
other milk mlxtures or the like.
Comparative experiment
The curative properties against dlarrhoea of the
preparation according to the invention were compared
by a controlled experiment with the properties of
Calmix neo at a Dutch calf fattening station.
For the experiments there were used in all 230 calves
which were divided in 5 groups of 46 animals each.
They were placed in wooden pens with floor grating
and being ventilated. One week old calves were used.
The animals were weighed before the experiment, after
29 days and after 58 days. At the beginning there
is given 1.5 1~ water and 75 g electrolytes as first
feeding. The fodder consisted of a bag of Heftica per
calf followed by Hemeka*start and fattening accord-
ing to the usual scheduIe.
In case of diarrhoea either the preparation accord-
ing to the invention or Calmix neo is given.
e~1~t~ a~e ~rMf ~
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1 The experiment results are given in the table below.
Average results Conservative Preparation
Curative treatment treatment according to
(Calmix neo) the invention
No. of calves 15 15
Average weight
at start 41.6 kg 38.3 kg
after 29 days 47. 5 kg 45.3 kg
58 days 74.4 kg 73.7 kg
,~ Average weight g~n
after 29 days 5.9 kg 7.0 kg
58 days 32.8 kg 35.4 kg
Average weight ga,n
after 29 days 5.9 kg 7.0 kg
29-58 days 26.9 kg 28. 4 kg
ga~n
Average Weigh~/day
after 29 days 203 g 241 g
59 days 565 g 610 g
25 The curative properties of the preparation prove to
be good. A~ter 58 days the calves showed an average
of 2.6 kg larger growth than the control group which
was treated with Calmix neo. Moreover, the average
weight per day among the animals which were treated
30 with the preparation according to the invention,
increased in the second period more than the animals
treated with Calmix neo. This shows that not on~y
are the absorption and the digestive capacity of the
intestine less influenced but they are at the same
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1 time more quickly-~e~ea-~e~. This result supports the
fact that the pharmacokinetics of the preparation
according to the invention builds on a protection
of the intestinal wall against pathogenic attacks
coupled with a compensation for lack of lactase by
means of acid resistant lactase whereby the secre-
tion as well as the osmotic component are combatted.
Example 1
The preparation according to the invention can be
composed~ for example as follows:
2 . . .
1000 g contains:
15 Magnesium oxide 5.75 g
Citric acid 13.50 g
Potassium chloride 24.00 g
Sodium citrate 26.50 g electrolytes
Sodium chloride 41.50 g
20 Sodium bicarbonate 68.oG g
Glucose 350.00 g
Terra rubrum 2.50 g dyestuff
25 Wheat bran 68.co g roughage
Isphagola husk
(dried seed coats of
plantago o~ata) 400.00 g absorbent fibre
Lactase 0.25 g enzyme
Total 1000.00 g
~ 12 ~59~
1 The individual ingredients, al.l of which are available as
dry powders, are mixed mechanically and are thereafter
immediately ready for use.
The agent according to the invention must n~t be
adminlstered in dry form, but must be suspended in water
and administered as a solution or suspension. The
intumeseenee occurs hereafter in the intestinal eanal
during a suitable period, whereby by absorption of fluid
10 said intumeseent swells up and gives the eontents of the
intestine a suitable eonsisteney, and binds and receives
some of the bacteria and their toxins so that a diarrhoea
is at once stopped. An intumescent being capable of
being swollen up by water may be deseribed as a water
15 binding swelling agent.
Example 2
The reparation aceordin to the invention can also
P g
have the followin~ composition which is particularly
preferred for human application:
1000 g contains:
Magnesium oxide6.17 g
Citric acid14.50 g
Potassiu~ chloride 25.75 g
Sodium cikrate28.45 g
Sodium chloride44.56 g
Sodium bicarbonate 73.00 g
Glucose 375.80 g
Isphagula husk,
crushed 429.50 g
Lactase 0.27 g
Oil of peppermint 2.00 g
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13
1 Example 3
A suspension or solution of the preparation prepared
in example 1 is produced by mixing 50 g preparation
to 1 liter of water. The pH-value in the fresh prep-
aration is 8.56. By filtration to a pH-value of 5.73
there is used 40.5 meq hydrochloric acid which shows
that there is a not inconsiderable Buffer effect
in the preparation which will "neutralise" the hydro-
chloric acid in the stomach and consequently protectthe lactase.
The chemicals used in the examples are ordinary
commercial chemicals and the lactase is preferably
CHBS lactase 25.000 from Chr. Hansens Laboratorium,
Copenhagen.
