HU187414B - Process for producing cough-preparation of physiologically relieving and sedative effect, fixable on skin - Google Patents

Abstract

The invention relates to a method for producing a synergistic pharmaceutical composition used for breastfeeding cough. With the invention, the production of a permanently convenient and practically applicable composition is made possible, which constantly ensures the antitussive effect by the sustained release of the active ingredients. The object of the invention is to provide a process for the preparation of a convenient and practically applicable composition which has an antitussive effect. According to the invention, the object is achieved by mixing pork fat, eucalyptus oil and optionally mustard.

Description

FIELD OF THE INVENTION The present invention relates to a process for the preparation of an anti-cough formulation having a physiologically soothing and calming effect on the skin.

It is known that cough suppressors are mostly synthetic drugs [e.g. Codein (morphine monomethyl ether)], respectively. various galenic formulations are used (aniseed expectorant, eucalyptus oil or thymol containing elixir). Folk medicine uses lard to suppress cough.

The disadvantage of synthetic drugs is that they usually contain irritating alkaloids, so some preparations are on the list of doping agents. Alkaloids may also have adverse effects on the heart, in particular. However, the effects of galenic formulations are relatively weak.

French Patent No. 71.37,158 describes an aid which is useful in the treatment of colds and bronchitis. According to the above patent, a rectangular shawl with a hole in the center for the head is soaked with 1-10 g / m ^{2 of} essential oil such as menthol, thymol, eucalyptus oil, camphor or a mixture thereof and applied tightly to the neck. However, the description does not mention that the shawl has any antitussive, prolonged or other practicable effect, but its practical application is very difficult. The desired effect is achieved by using only a relatively small amount of essential oil known to have a weak effect.

It has been an object of the present invention to provide a composition that is durable, convenient and practical, that provides continuous cough suppression through sustained release of the active ingredients, with no or at least no topical side effects and no toxic material at all.

According to the present invention, a skin-fastening, physiologic and sedative antitussive composition is prepared by using lard fat, eucalyptus oil and, if desired, an antioxidant and mustard 700-1200: 2.5-50: 0.1-5: 70-160 admixed by weight, if no antioxidant is used, sterilized, impregnated with a hydrophobic carrier, optionally coated with one side of the carrier prior to or after application of the mixture, optionally coated with an adhesive to the skin and desired in this case, the substrate materials are covered with a removable protective layer.

The effect of the composition according to the invention is provided by the lard, eucalyptus oil and mustard, if desired. The addition of mustard is not necessarily necessary, but its effect is enhanced by its presence.

The active ingredient in lard is predominantly prostaglandin and, on the other hand, the effect of volatile fatty acids (triglycerides) on the inner cilia of the bronchi can be taken into account. The mustard oil of the 60 mustard antitussive, antitussive substance. The cough suppressant effect of eucalyptus oil is also known, although perfection of the composition was also an important aspect of the present invention.

The effect of the composition according to the invention is not significantly greater than the sum of the effects of the generally poorly known pig fat, eucalyptus oil and mustard.

After application, the product acts partly transdermally and partly by evaporative inhalation, the temperature required for the latter being provided by the constant temperature of the human body.

The composition may also be sterilized if necessary, but preferably with a small amount of antioxidant to provide sufficient chemical microbiological stability. Preferably, the antioxidant used is butylhydroxytoluene, which is used to inhibit pig fat cover.

Preferably, the hydrophobic carrier used in the composition of the invention is gauze or terry cloth.

To prevent dehydration or leakage of the active ingredients on the back of the patch, it is preferable to impregnate the carrier with, for example, a plastic, such as polyvinyl chloride, or a carrier having a dense web on one side. The insulation may also be achieved by gluing a suitable insulating material, preferably aluminum or plastic foil, to the substrate.

The carrier impregnated with the mixture according to the invention may itself be placed on the in-patient's chest, but preferably the carrier is affixed to the patient's skin. The attachment may be by applying adhesive strips on both sides to the patient's skin with adhesive strips, or it may be done by applying the carrier to an adhesive larger than its size, the portions of which extend over the support to the patient's body surface. Preferably, the adhesive is leukoplast or a similar adhesive commonly used in medicine.

In the case of the composition according to the invention, the side of the carrier impregnated with the pharmaceutical composition which is in contact with the skin is preferably covered with a protective layer which can be removed before use. Polyvinyl chloride, polyethylene or aluminum foil is preferably used as the protective layer.

A preferred embodiment of the composition according to the invention is represented by i. Figure 4A. The composition shown in the figure is prepared by impregnating the terry cloth 1 with 250 to 2500 g / m ² of the active ingredient mixture described above, gluing polyvinyl chloride 2 or other foil on one side, placing it on the leukoplast 3 and later on, the skin-contact side is covered with 4 removable polyvinyl chloride or polyethylene films. The composition according to the invention is preferably a square or rectangle having a side length of 10-20 cm.

Advantages of the composition according to the invention are:

- no side effects, no toxic effects as the active ingredient used is a food grade food grade material;

- its effect can be felt within 10-15 minutes, lasts for 6-8 hours, after which, without any difficulty and possible harmful consequences, another patch may be applied to the chest;

- can be applied easily and quickly regardless of the patient's age and time of day.

The preparation composition according to the invention is illustrated by the following Examples ¹⁰ to limit the invention to the scope thereof.

Example 3

750 g of pork fat, 2.5 g of eucalyptus oil and 75 g of mustard are mixed and the mixture is sterilized. After sterilization and cooling, this material is impregnated with a hydrophobic 10x15 cm textile material, and an equivalent size polyvinyl chloride film is glued to the side of the textile material that will not come in contact with the skin surface. The substrate is applied to a 12 x 17 cm hansaplast adhesive and the skin-contact portion is covered with polyethylene film.

Example 1 ¹³

1000 g of pork fat, 3 g of eucalyptus oil, 0.1 g of butylhydroxytoluene are mixed and a 10 x 20 cm terry cloth is soaked. The side of the terry cloth that is not in contact with the skin ^{2 is} densely woven to prevent evaporation of essential oils and penetration of fat. The carrier thus obtained is applied to a 13 x 13 cm piece of leukoplast, and the skin-contact side of the terry cloth is covered with polyvinyl chloride film. ²⁵

Example 2

1200 g of lard, 43 g of eucalyptus oil, ³⁰ 3 g of methyl capsular hydroxy toluene and 90g mustard were mixed, and then impregnated with this mixture through a 20 x 20 cm piece of gauze. One side of the gauze impregnated with polyvinyl chloride and two opposite sides adhered adhesive bandage strip ³⁵ is fixed to the patient's chest.

Example 4

1200 g of pork fat, 160 g of mustard, 18 g of eucalyptus oil and 3 g of butylhydroxytoluene were mixed with a 20 x 20 cm piece of terry towel and then placed on the chest of a child with bronchitis.

The efficacy of the composition of the invention is demonstrated by the following clinical data:

a) In the treatment of 17 groups of patients with asthma and bronchitis at night, the cough was completely eliminated in 8 cases, significantly reduced in 5 cases and less in 4 cases. No adverse or harmful side effects have been reported.

b) 4 bilateral children with chronic bronchitis were treated with the patch according to the invention. Coughing has been significantly reduced as a result of a single treatment and the hearing findings have improved in all four cases.

(c) Treatment and examination of a population of 10 cases according to the following results:

Name Age / no Diagnosis Comment K. G. 42 / male. Ac. Viral pneumonia Other cough suppressants were optional. No. L. 39 / male. Ac. Tracheobronchitis The nighttime cough was removed by the patch. Ny. M. 42 / female A form of asthma bronchiale essentialis The patch significantly reduced the intensity and duration of the cough. The patch has been used by the patient ever since. Ny. K. 44 / female Tracheomalacia The number of crises decreased and the intensity of cough decreased. M.L. 56 / FII. Mr. Bronchitis akutozált section The cough decreased during the night and the patient's sleep was smooth. No. E. 36 / female Ac. Viral upper respiratory tract disease The patient coughed after the first 20 minutes. 4 cases pleuritis of post-thoracytomic origin The cough has practically disappeared.

d) 10 patients 1-4 years old and 10 patients aged 5-14 years obstructive bronchitis, bronchial asthma or have been treated for bronchopneumonia. The patch was used as an adjunct to basic medicines in the evening in bed for young children and in the evening and in the day for older children. Toddlers (1-4 years) became significantly calmer after applying the patch, falling asleep better, while struggling with severe shortness of breath before applying the patch. The effect of the patch is approx. Decreased after 2 hours.

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Older children clearly reported that their choking, breathlessness, well-being and mood improved. The effect of the patch diminished after a few hours.

The only side effect of the patch was that the leukoplast irritated children's skin.

e) 17 adults with asthma and / or asthma. in patients with bronchitis. The patch applied overnight resulted in the elimination of cough in 8 cases, relief in 5 cases and ineffective application in 4 cases. ¹⁰

(f) comparative testing.

a patient with asthma was given lard overnight. In 2 patients, the intensity of coughing attacks decreased slightly, and in 4 patients, the compress was ineffective. ⁵

Claims (6)

A process for the preparation of an anti-cough formulation having a physiologically soothing and calming effect on the skin, characterized in that: - lard, eucalyptus oil, optionally an antioxidant and mustard 700-1200: 2.5-50: 0.1-5: 70-160 weight ratio of ²⁵ were mixed; impregnating the mixture with a carrier; - optionally providing the carrier with elements suitable for attachment to the skin surface; optionally, the substrate is covered with a removable protective layer. (Priority: 12/10/1984) Composition according to claim 1, characterized in that one side of the carrier material is coated with an insulating material before or after the mixture is soaked. (Priority: 12/10/1984) 3. The composition of claim 1 wherein the antioxidant is butylhydroxytoluene. (Priority: September 23, 1982) Composition according to claim 1, characterized in that the carrier preferably comprises porous paper, gauze, terry towel. (Priority: 12/10/1984) Composition according to Claim 1, characterized in that it preferably comprises a leukoplasty strip (s) or a perforated polyvinyl chloride film in the form of a skin-fastening element. (Priority: 23/09/1982) Composition according to claim 1, characterized in that it comprises a strip of paper or a plastic film as a removable protective layer. (Priority: 10/12/1984)