LU85365A1 - METHOD AND PREPARATION FOR STIMULATING THE IMMUNE SYSTEM - Google Patents

Description

«_ 1 A 50 778 1.4.5.84.

Method and preparation for stimulating the immune system

The invention relates to a method and a preparation for stimulating the immune system of living human and animal organisms. When used, cell damage and other harmful side effects in the treated organisms should be avoided.

The inventive method is characterized in that ingredients of ethereal oil drugs soluble in organic solvents are used.

that the ingredients are administered in daily doses of 10 to 1000 mg (milligrams), preferably 5 to 100 mg, per 70 kg (kilograms) of weight of the living organism and that the daily doses are administered in a period which does not exceed two days Number of daily doses to be administered.

These ingredients show an immune system stimulating effect when used in a concentration that is one or more powers of ten lower than the concentration at which these ingredients have toxic effects on life! show cells.

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Since these ingredients can be obtained from ethereal oil drugs which have proven themselves for human and animal nutrition for many years and have proven to be harmless in the dosage in question, the amounts to be used according to the invention can also be expected the ingredients do not cause serious harmful side effects.

i i | Depending on the circumstances, treatment is recommended! such that the daily doses are administered on consecutive days, or such that the administration of the

Daily doses with the inclusion of break days, on which no ingredients are administered, and that the break days are combined into one to three breaks of approximately the same length, which vary evenly over the treatment period! / shares.

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Examples of the administration of the daily doses during the treatment period are shown in the table below.

0 TABLE 1

Number the length of the numbering numbering the

Daily doses of action time- the days in days of the treatment room in days within the lung period,

Treatment- where no period f of daily doses are followed - daily doses are administered - doses are followed (break days) (dose days) 10 10 1st - 10th ---- 20 40 1st - 10th 11th - 30th

31st - 40th

30 30 1st - 30th ---- 30 40 1st-15th 16.-25 * 26.- 40.

30 45 1st - 10th November - 20th

21st - 30th 31th - 35th _36th - 45. _ 30 50 1.-10. 11th - 20th

21st - 30th 31th - 40th

__41. - 50.__ 35 35 1st - 35th --- 40 ____ 40 1st - 40th - ------ 50 90 1st - 10th 11th - 20th

21st - 30th. 31st - 40th

41 * - 50. 51. - 60.

61.- 70. 71. - 80.

_81. - 90th _

Ingredients which can be obtained from ethereal oil drugs by steam distillation are preferably used.

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Black pepper oil, cinnamon blossom oil, cardamom oil, linallyl acetate, cinnamaldehyde, safrol, carvone and cis / trans citral have proven themselves as ingredients.

In addition, a mixture of the following essential oils in the alcoholic distillate of 536 mg Folia Melissae, 714 mg Rhizoma Helenii, 714 mg Radix Angelicae, 714 mg Rhizoma Zingiberis has proven to be an effective ingredient. 285 mg Flores Caryophylli,, 285 mg Rhizoma Galangae, 714 mg Radix Gentianae, 321 mg Cortex

Cinnamomae and 71.4 mg Fructus Piperis nigri. This mixture is called special mixture below.

Mixtures of the ingredients mentioned, including the special mixture, have also proven their worth.

A pharmaceutical preparation according to the invention, i.e. for stimulating the immune system of living human and animal organisms, is produced by one or more of these ingredients by steam distillation, by dissolution with an organic solvent, for example water or alcohol, or by squeezing from those essential oil drugs , in which the relevant constituents are contained, are obtained and then in a pharmaceutical application vehicle in a mixing ratio of 0.2. : 100 to 40: 100 can be mixed in.

The following ingredients can be obtained from essential oil drugs by steam distillation, as follows:

Black pepper oil from the fruit grains of Piper nigrum; Cinnamon blossom oil from the flowers of the cinnamonum cassia;

Cardamom oil from the seeds of Elettaria cardamomum; Linallyl acetate from the flowers of the Lavandula;

Cinnamaldehyde from the bark of the cinnamonum ceylanicum;

Sassafras Root Saffron}

Carvon from the fruit of the Carum carvi and. cis / trans Citral from the leaves of the cymbopogon citratus.

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A pharmaceutical preparation according to the invention, ie for stimulating the immune system of living human and animal organisms, consists of one or more of the ingredients which are mixed into a pharmaceutical application vehicle in a mixing ratio of 0.2: 100 to 40: 100.

The effect which can be achieved with the invention is demonstrated by comparative tests as follows.

Experiments were carried out on rabbits who received the corresponding ingredients in drinking water for 42 consecutive days, namely a first group of animals in a daily dose of 5 mg to 70 kg live weight and a second group of animals in a daily dose of 50 mg to 70 kg live weight.

After the 42 days, the animals were infected with a herpes PSR virus. A control group of animals that had not been pretreated had a lethality of 95%, i.e. a survival rate of 5%.

Rabbits were treated with cinnamaldehyde, with black pepper oil and with a special mixture.

The rabbits pretreated with cinnamaldehyde had a survival rate of 70% t, the rabbits pretreated with special mixture had a survival rate of 33% and the rabbits pretreated with black pepper oil had a survival rate of 17%

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The immune parameters of the treated animals were continuously checked during the experiments. After the infection *, the pretreated animals showed an increase in the immune parameters, in some cases up to the 40th day after the infection. duplication compared to the primary values. This increase in immune parameters was not observed in the animals that had not been pretreated. In addition to the reduction in mortality, an increase in the immune fractions can thus be observed by the pretreatment, which proves that the immune system was stimulated by the pretreatment.

The experiments were repeated on rats and showed the same results.

Cell cultures were created from the permanent strains of the cell types "Girardi Heart" (GH), "Flow 12000" (FL), "Intestine 407" (IN) and "Vero Kidney" (VE) and each treated with an ingredient in different dosages. The harmful dosage was shown by the fact that cells clumped together. The harmless doses are given in TABLE 2.

The table shows that the dosage used in animal experiments is far below that which is harmful to living cells.

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TABLE 2

Ingredient-treated area of the virucidal substance concentration, at which no cell substance damage was observed, in mg ingredient based on 10 kg of treated cell substance

Black pepper oil,. n

(Oleum piperis nigri) D1S

”FL to 0.1" IN to 1 _ "_ VE_bis 0.1_

Cinnamon blossom oil,.

(Oleum cassiae flores) D1S υ, Ί "fl to 0.1" IN to 0.1 <"_ve__to 0.1_

Cardamom oil. .

(Oleum cardamomi) bil D1S 1 "FL to 1" IN to 1 _ »_ VE_bis 10_

Linallyl acetate GH up to 0.1 "FL up to 1" IN up to 1 __VE_bis 1_

Cinnamaldehyde GH to 1 "_ FL to 1" ___________. IN__ to 1 _ü ___ VE_bis 1_

Safrol GH up to 1 "FL up to 1" IN up to 10 »_._ VE_bis 1_

Carvon GH to 1 "FL to 1» · IN to 1 "_ VE_ to 1_

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'TABLE 1 - continued *

Ingredient-treated area of virucidal concentration, in which no cell damage was observed, in mg ingredient based on 10 kg of treated cell substance cis / trans Citral GH to 1 »FL to 1» IN to 1 »VE to 1 / * φ - 8 - A 50 778 14.5.84.

Example 1 (solution for injection) 100 g (grams) of black pepper oil are dissolved in 2 1 (liters) of 1,2-propanediol. The solution is sterilized at 121 ° C (Celsius) for 50 minutes in an autoclave, then cooled and poured into ampoules in 2 g portions.

One ampoule contains 10 mg black pepper oil and contains an average daily dose for a 70 kg adult to stimulate the immune system. This daily dose is used for 20 to 45 consecutive days. The mixing ratio of the ingredient used to the 1,2-propanediol is 5: 100 in this example; other mixing ratios for injection solutions are also possible, namely in the range between 0.4: 100 and 10: 100, but the daily dose of the injection solution must then be adapted to the changed content of the injection solution content.

Example 2 (solution for injection)

As example 1 with the only difference that 100 g of cinnamaldehyde are used instead of the 100 g of black pepper oil.

Example 3 (injection solution) s As example 1 with the only difference that 100 g of the special mixture are used instead of the 100 g - ^ black pepper oil.

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* Example 4 (aerosol), 650 g black pepper oil are mixed in 631 g ether mixed with 1 805 g ethanol. 31 g of castor oil fatty acid esters with oxyethylated glycerol and 210 g of caprylic / capric acid triglyceride are mixed into this solution. 0.536 g of this mixture are filled into spray cans together with 0.505 g of difluoro-dichloromethane as blowing agent. The spray cans are closed and have a metering valve which releases a predetermined portion of the mixture with each actuation, which is then sprayed as an aerosol under the pressure of the difluoro-dichloromethane.

Appropriate setting and dimensioning of the metering valve ensures that a single dose with each actuation. with 5.0 mg black pepper oil is released.

To treat and prevent flu-like infections, aerosol is sprayed into the mouth or nose and inhaled. For an adult weighing 70 kg, ten such spray servings per day with a total of 10 x 5 mg = 50 mg black pepper oil are an advantageous treatment.

In this example, the mixing ratio of the ingredient used to the aerosol substance is 24: 100; other mixing ratios for the aerosol are also possible, specifically in the range between 2: 100 to 40: 100, but the daily dose must then be adjusted to the modified content of the ingredient in each spray portion.

Example 5 (capsule)

A capsule filling is made from 50 g cinnamaldehyde and 3 g soy lecithin as an emulsifier. Each capsule contains 53 mg of this capsule filling and is enclosed in a capsule shell, which consists of 87.5 mg gelatin and 37.5 glycerin.

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- 10 A 50 778 May 14, 1984.

To stimulate the immune system, such a capsule w is administered orally to the 70-leg adult patient per day for 20 to 45 consecutive days.

Such a capsule contains 50 mg of cinnamaldehyde. Other capsule fillings are also possible, namely in the range between 1 to 100 mg, but the daily dose must then be adjusted to the changed content of the ingredient.

Example 6 (capsule)

As example 5 with the only difference that 50 g black pepper oil are used instead of the 50 g cinnamaldehyde.

Example 7 (capsule)

As example 5 with the only difference that 50 g of the special mixture are used instead of the 50 g of cinnamaldehyde.

Example 8 (ointment) 3.0 g paraffinum durum and 87.0 g white petroleum jelly are heated to 60 ° C. and stirred. 20 g of cinnamon blossom oil are mixed into the warm mixture. The mixture is cooled and can be used as an ointment for topical application. About 0.1 ml of ointment - which contain about 10 mg of ingredient - are distributed p on 50 cm of skin. This can be repeated 8 times a day ”.

The mixing ratio of the ingredient used to the mixture of paraffinum durum and white petroleum jelly is 22: 100 in this example; other mixing ratios for the ointment are also possible, in the range between 2; 100 to 40: 100.

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Claims (10)

1. A method for stimulating the immune system of living human and animal organisms, characterized in that soluble ingredients of ethereal oil drugs are used in organic solvents, - * that the ingredients are administered in daily dosages of 10 to 1000 mg (milligrams), preferably 5 to 100 mg, to 70 kg (kilograms) weight of the living organism and that the daily doses are administered in a period which does not comprise more days than twice the number of daily doses to be administered. 2. The method according to claim 1, characterized in that the administration of the daily doses takes place on successive days. 3. The method according to claim 1, characterized in that the administration of the daily doses with the inclusion of break days, on which no ingredients are administered, and that the break days are combined into one to three approximately equally long breaks, which are uniform over the period of the treatment are distributed. 4. The method according to claim 1, characterized in that by ¥ water vapor destination from ethereal oil drugs. bare ingredients are used. 5. The method according to claim 1, characterized in that black pepper oil, cinnamon blossom oil, cardamom oil, linallyl acetate, cinnamaldehyde, safrol, carvone, cis / trans citral, or a mixture of the following essential oils are used as ingredients in the alcoholic distillate of 536 mg Folia Melissae ,. 714 mg Rhizoma Helenii, 714 mg Radix Angelicae, 714 mg Rhizoma Zingiberis, 285 mg Flores Caryophylli, 285 mg Rhizoma Galangae, 714 mg Radix Gentianae, 321 mg Cortex Cinnamomae and 71.4 mg Fructus Piperis nigri (= so-called special mixture) or Mi / creations from the named ingredients. , ~ 12. A 50 778 14.5.84. 9 6. Pharmaceutical preparation for stimulating the immune system of living human and animal organisms, according to claim '1, 2 or 3 », characterized in that one or more of the ingredients listed in claim 4 or 5 in a pharmaceutical application vehicle in a mixing ratio of 0.2: 100 to 40; 100 are mixed in. Î ~ * j 7 · Pharmaceutical solution for injection according to claim 6, characterized- j 'indicates that one or more of the ingredients in 1,2-; Propanediol in a mixing ratio of 0.4: 100 to 10: 100, pre- | preferably in a mixing ratio of 5: 100. 8. Pharmaceutical aerosol according to claim 6, characterized in that one or more of the ingredients in an aerosol substance in a mixing ratio of 2: 100 to 40; 100, preferably in a mixing ratio of 24: 100, and that the aerosol substance consists of 1 part ether, 2 to 5 parts ethanol, 0.02 to 0.1 part ester of castor oil fatty acids with oxyethylated glycerol and 0.2 to 1 part caprylic / capric acid. Triglyceride exists and is under the propellant pressure of 2 to 6 parts of difluoro-dichloromethane. 9. Pharmaceutical, ingestible capsule according to claim 6, characterized in that a capsule shell is provided which completely encloses a capsule filling and that the capsule filling from 1 to 100 mg, preferably 50 mg, of one or more of the: ingredients finite 1 to 8 mg soy lecithin as an emulsifier "and that the capsule shell consists of gelatin and glycerin in a mixing ratio of 3: 1 to 2: 1 and that the total weight of the capsule is 80 to 200 mg. 10. Pharmaceutical ointment according to claim 6, characterized in that one or more of the ingredients in a mixing ratio of 2: 100 to 40: 100, preferably in a mixing ratio of 1: 22: 100, are mixed into the ointment carrier and that the ointment carrier from Paraffinum durum is mixed with white petroleum jelly in a mixing ratio of 1:20 to 1:35. i