Combination drug for the relief of symptoms of colds and flu (options)

 

(57) Abstract:

The invention relates to the field of medicine and relates to means for the prevention and treatment of colds and flu. Proposed combination drug for the relief of symptoms of colds and flu, containing at least one non-steroidal anti-inflammatory drug (NSAID) or its mixture with caffeine, at least one analgesic selected from the group comprising Metamizole, venison, propyphenazone, Ketorolac, codeine, pentazocine, nalbufin, butorphan, morphine, fentanyl, loperamide, piritramid, Tilidine, tramadol, naltrexone, at least one vitamin from the group comprising vitamin C, glaskolben, folic acid, rutin or bioflavonoid, and antihistaminic agent (options). Also proposed is a combination drug for the relief of symptoms of colds and flu, the combination of components comprising a mixture of at least one nonsteroidal anti-inflammatory drugs (NSAIDs) and one analgesic or one analgesic selected from the group comprising Metamizole, venison, propifenazona, Ketorolac, codeine, pentazocine, nalbufin, butorphan, morphine, fentanyl, loperamide, peritreme is or bioflavonoid and antihistaminic agent, housed in two separate dosage forms. The drug is an analgesic, antipyretic, anti-inflammatory, antiviral, antihistamine, significant angioprotective, antioxidant, anti-edema effect. The drug is a universal remedy for colds, flu, and other febrile conditions. 3 S. and 13 C.p. f-crystals, 5 PL.

The invention relates to the field of medicine and relates to means for the prevention and treatment of colds and flu.

To colds include a variety of acute infectious diseases and exacerbation of chronic diseases, especially of the upper respiratory tract.

Names of colds correspond to anatomical formations, from top to bottom: nasal cavity, pharynx, larynx, trachea and bronchi. Accordingly, occur the names of diseases: rhinitis, pharyngitis, laryngitis, tracheitis, bronchitis.

Before they were United in the group of acute respiratory disease (ARD), scientists are now doctors believe the more correct name of acute respiratory viral infections (ARVI).

Influenza and ARVI occupy the first place in terms of frequency and number of cases in the world and is 95% all about 1 year. People spend these months in the active condition, suffering from fever, General weakness, headache, poisoning the body of toxic viral proteins.

The term "acute respiratory infection (ARI) covers a large number of diseases that are largely similar to each other. Their main similarity is that they are all caused by viruses that may enter the body inhaled through the mouth and nasopharynx, and that they all have the same set of symptoms. Patient a few days there is increased body temperature, sore throat, cough, headache. The most common disease is acute rhinitis (runny nose), it is called a whole series of related viruses known as rhinoviruses. When the recovery of all these symptoms disappear and not leave behind any traces. There are bacterial and mycoplasmal forms of diseases. Call them streptococci, staphylococci, pneumococci and many other bacteria or Mycoplasma. Such diseases often do not arise on their own, and join virus (SARS) or occur on a background of chronic respiratory diseases. Flu is caused directly Viru who have cardiovascular system, cutting for a few years, the average duration of human life. In severe flu often have irreversible damage to the cardiovascular system, the respiratory organs, the Central nervous system causing heart disease and blood vessels, pneumonia, traheobronhity, meningoencephalitis.

The basic steps in the treatment of influenza and ARVI aimed at reducing severe symptoms. In the acute phase of the disease is recommended bed rest, rest, drink plenty of water.

When the temperature used different antipyretics (paracetamol, ibuprofen, aspirin).

To reduce nasal congestion use vasoconstrictive drops (naphazoline, galazolin, xymelin and so on). Also on the evidence used antihistamines.

To increase the resistance of the body to use vitamins such as vitamin C (ascorbic acid) and vitamin A.

Also for treatment of influenza using drugs interferon-based.

There are a number of anti-influenza drugs that are not in common with the body, and directly to the influenza virus. This is such well-known drugs like amantadine and rimantadine. These medications have a number shall be the respiratory apply antimicrobial agents (including antibiotics).

The etiology of this group of diseases makes it impossible solution to the problem of reducing the incidence only at the expense of vaccination, and therefore does not weaken the role as chemotherapeutic agents that increase the resistance of the human body, and various symptomatic means.

Recently, researchers in this field of medicine are preferred to the creation of the combined preparations of complex actions.

The most famous of this group of drugs are the following:

- drug Coldrex Hotrum company Glaxo Smith Kline on the basis of paracetamol, phenylephrine hydrochloride and ascorbic acid in the form of a powder for solution;

- drug Fervex UPSA containing Pheniramine maleate, paracetamol, ascorbic acid;

- PENTAFLUORO capsules containing aspirin, vitamin C, rutin, calcium lactate and diphenhydramine (EN 2173555 C1);

the premise of the company Naturprodukte tablets containing paracetamol, ascorbic acid and chlorphenamine;

the premise granules containing aspirin, vitamin C, diphenhydramine, rutin, calcium gluconate (EN 99102949 A1).

- Powergen company Pliva in the form of tablets containing paracetamol, antipyretic effect. However, they did not effectively reduce the risk of developing complications from the flu, which, as noted above, there are frequent and very dangerous. In addition, many of these drugs do not have sufficient duration of shelf life.

The present invention is to expand the range of cold and flu funds through the creation of new combination drugs, quickly eliminate the symptoms of colds and reduce the risk of developing complications from the flu with high efficiency.

The problem is solved by the creation of new combination products. One of the options is a drug based pharmaceutical compositions containing at least one non-steroidal anti-inflammatory drug (NSAID) or its mixture with caffeine, at least one analgesic selected from the group comprising Metamizole, venison, propifenazona, Ketorolac, codeine, pentazocine, nalbufin, butorphan, morphine, fentanyl, loperamide, piritramid, Tilidine, tramadol, naltrexone, at least one vitamin selected from the group comprising vitamin C, glaskolben, folic acid, rutin or bioflavonoid, antihist is optional to contain acceptable salt of calcium, such as lactate or calcium gluconate.

NSAIDs can be selected from the group: paracetamol, aspirin, aalisin, sodium salicylate, salicylamide, phenylbutazone, ibuprofen, diclofenac, indomethacin, naproxen, oxaprozin, Ketoprofen, sulindac, tolmetin, zomepirac, mefenamovaya acid, niflumova acid, diflunisal, etodolac, piroxicam, meloxicam, lornoxicam, nabumeton, Dimexidum.

As an antihistamine drug can be included blockers N1-histaminic receptors, such as diphenhydramine, diphenhydramine, dimenhydrinate, fenkarol, biorphen, promethazine, Dimebon, diasorin, suprastin, tavegil, cetirizine, setaction, astemizole, cyproheptadine at, loratadine, terfenadine, asbestine, chlorphenamine; substances inhibiting the release of histamine and other mediators of Allergy and inflammation, for example kromolin sodium, ketotifen, oxatomide.

As bioflavonoids can be included, for example, quercetin, baicalein.

Another option according to the invention is a drug recommended for patients with disorders of the gastro-intestinal tract, prone to allergic reactions, and consequently those who are not recommended to use NSAIDs. The drug is made on the basis of pharmacy shall Eason, propyphenazone, Ketorolac, codeine, pentazocine, nalbufin, butorphan, morphine, fentanyl, loperamide, piritramid, Tilidine, tramadol, naltrexone, or its mixture with caffeine, at least one vitamin from the group comprising vitamin C, glaskolben, folic acid, rutin or bioflavonoid, antihistaminic agent, and optionally pharmaceutically acceptable excipients. The drug may also optionally contain acceptable salt of calcium, such as calcium lactate or calcium gluconate.

The preparations according to the invention can be made in the form of powders, granules or other acceptable dosage forms such as tablets, capsules, syrups, solutions or suspensions for oral administration.

Depending on the required form of the introduction are used pharmaceutically acceptable excipients. Most preferably the use of water, glycerin, microcrystalline cellulose, cellulose derivatives, PVP, starch and its modifications, sugars such as lactose and glucose, apadravya, moving, perfumes, etc.

Improving the bioavailability and effectiveness of the compositions can be achieved with the introduction of as excipients Apple withdraws arinate in pharmacy methods.

The dose of the ingredients can vary depending on the severity of the disease, sex, age, presence of concomitant diseases and nature of the substances. Preferably the dose of NSAIDs is from 20 to 500 mg, non-narcotic analgesics from 5 to 500 mg, opioid analgesics from 1 to 10 mg, antihistamine drugs, from 1 to 50 mg, vitamin C or galascorbinum acid from 5 to 500 mg, rutin 20-100 mg, folic acid 0.5-1 mg, bioflavonoids 10-200 mg of calcium 50-300 mg.

The drug is an analgesic, antipyretic, anti-inflammatory, antiviral, antihistamine, significant angioprotective, antioxidant, anti-edema effect. Almost new drug is a universal remedy for colds, flu, and other feverish conditions.

Another option according to the invention is a combination drug, which is a set - a combination of components comprising a mixture of at least one nonsteroidal anti-inflammatory drugs (NSAIDs) and at least one analgesic or at least one analgesic selected from the group comprising Metamizole, venison, propifenazona, Ketorolac, codeine, pentazocine, n is Dean of the vitamin from the group including vitamin C, glaskolben, folic acid, rutin or bioflavonoid, antihistaminic agent, and optionally pharmaceutically acceptable auxiliary substances placed in at least two separate unit dosage forms. Developed combination can significantly extend the shelf life of drugs.

In the case of two-component set of one form includes one or more NSAIDs, at least one vitamin. The second form includes an analgesic selected from the group comprising Metamizole, venison, propifenazona, Ketorolac, codeine, pentazocine, nalbufin, butorphan, morphine, fentanyl, loperamide, piritramid, Tilidine, tramadol, naltrexone, or its mixture with a calcium salt, an antihistamine optionally auxiliary substances.

In the case of a three-component set of one of the forms contains a mixture of NSAIDs and analgesic or analgesic selected from the group comprising Metamizole, venison, propifenazona, Ketorolac, codeine, pentazocine, nalbufin, butorphan, morphine, fentanyl, loperamide, piritramid, Tilidine, tramadol, naltrexone, if necessary, pharmaceutically acceptable additives; the second form includes at least one vitamin from the group vklyuchayuschaya excipients; the third form consists of an antihistamine or its mixture with a calcium salt, and optionally auxiliary substances.

Individual forms can be in the form of granules, tablets, capsules containing powder or granules, sachets.

The possibility of carrying out the invention can be confirmed by the following examples which serve to illustrate but not limit the scope of the invention.

Examples 1-5 are shown in table. 1.

Example 6

The syrup containing the following components, mg:

Paracetamol 250

Metamizole 50

Loratadine 20

Glaskolben 100

Sugar 500

Sodium benzoate 50

Citric acid 50

Propylene glycol 2 ml

Water To 100 ml

Examples 7-11 are presented in table.2.

The capsules contain powders or granules.

Example 12

Set

A two-part kit contains the components shown in table. 3.

a)

Three-part kit contains the components shown in table. 4.

a)

For ease of use by the patient each type of tablets or capsules has its color or shape. For example, one kapulnik in individual sachets (PL.5).

The invention was tested in the laboratory and in the clinic for volunteers.

Activity proposed combined drugs was studied in the laboratory in outbred mice by conventional tests.

Analgesic effect was studied by tests “hot plate”, “acetic cramps, pressure on the paw”.

Antipyretic activity was evaluated by the reduction of hyperthermia after 2 hours after injection of the analyte. Febrile reaction caused by the introduction of a 20% suspension of Baker's yeast.

Anti-inflammatory and anti-edema effect was evaluated on the model carragenine of paw edema in rats”. Acute inflammatory reaction (swelling) reproduce subplanetary the introduction of 0.1 ml of 1% aqueous solution carragenin. The intensity of the inflammatory reaction was evaluated 3 hours after induction of inflammation by changing the volume of the paws. Analyte injected probe into the stomach 1 hour before carrageenin. Anti-inflammatory effect was evaluated by the reduction of swelling.

Antihistamine effect was studied on the model of bronchospasm caused by aerosol exposure to histamine (1% solution).

Antiviral activity was studied in respect to the ions. Evaluation of the antiviral activity of the preparations was carried out by controlling the reproduction of the virus.

All tests show satisfactory results the investigated activities compared to control.

Studies on volunteers. In the group of patients who took the compositions according to example 1 and 2, there was a significant improvement already in 3-4 days. Lost the feeling of nasal congestion, headache, chills, pain in the joints and muscles, there was a relieved breath. The drug was well tolerated, with virtually no side effects.

The conducted research allows to make a conclusion about the high efficiency of the new combined drugs in the treatment of flu, colds and other feverish conditions with uncertain etiology. Presents the drugs allow you to resolve adverse symptoms associated with these diseases.

1. Combination drug for the relief of symptoms of colds and flu, characterized in that it contains at least one non-steroidal anti-inflammatory drug (NSAID) or its mixture with caffeine, at least one analgesic selected from the group comprising metamod, piritramid, Tilidine, tramadol, naltrexone, at least one vitamin from the group comprising vitamin C, glaskolben, folic acid, rutin or bioflavonoid, and antipruritic agent.

2. The drug under item 1, characterized in that it further comprises a pharmacologically acceptable salt of calcium.

3. The drug under item 2, characterized in that the specified calcium salt is calcium gluconate.

4. The drug under item 1 or 2, characterized in that it further comprises pharmaceutically acceptable excipients.

5. The drug according to any one of the preceding paragraphs, wherein the non-steroidal anti-inflammatory agent is contained in an amount of between 20 and 500 mg per unit dose.

6. The drug according to any one of the preceding paragraphs, characterized in that it is made in the form of capsules, tablets, syrup and sachets.

7. Combination drug for the relief of symptoms of colds and flu, characterized in that it contains at least one analgesic selected from the group comprising Metamizole, venison, propifenazona, Ketorolac, codeine, pentazocine, nalbufin, butorphan, morphine, fentanyl, loperamide, piritramid, Tilidine, tramadol, naltrexone, or, the duck or bioflavonoid and antipruritic agent.

8. The drug under item 7, characterized in that it further comprises a pharmacologically acceptable salt of calcium.

9. The drug under item 8, characterized in that the specified calcium salt is calcium gluconate.

10. The drug under item 7 or 8, characterized in that it further comprises pharmaceutically acceptable excipients.

11. The drug according to any one of the preceding paragraphs, characterized in that it is made in the form of capsules, tablets, syrup and sachets.

12. Combination drug for the relief of symptoms of colds and flu, characterized in that it is a combination of components comprising a mixture of at least one nonsteroidal anti-inflammatory drugs (NSAIDs) and at least one analgesic, or at least one analgesic selected from the group comprising Metamizole, venison, propifenazona, Ketorolac, codeine, pentazocine, nalbufin, butorphan, morphine, fentanyl, loperamide, piritramid, Tilidine, tramadol, naltrexone, at least one vitamin from the group comprising vitamin C, glaskolben, folic acid, rutin or bioflavonoid, antihistamines means is I, it contains two separately placed dosage forms, one of which includes one or more NSAIDs, at least one vitamin, and the second format includes at least one analgesic selected from the group comprising Metamizole, venison, propifenazona, Ketorolac, codeine, pentazocine, nalbufin, butorphan, morphine, fentanyl, loperamide, piritramid, Tilidine, tramadol, naltrexone, or its mixture with a calcium salt, an antihistamine.

14. The drug under item 12, characterized in that it contains three separately housed dosage forms, one of which includes a mixture of at least one NSAID and at least one analgesic or at least one analgesic selected from the group comprising Metamizole, venison, propifenazona, Ketorolac, codeine, pentazocine, nalbufin, butorphan, morphine, fentanyl, loperamide, piritramid, Tilidine, tramadol, naltrexone, the second form includes at least one vitamin from the group comprising vitamin C, glaskolben, folic acid, rutin or bioflavonoid, the third form consists of an antihistamine or its mixture with a salt of calcium.

15. The drug according to any one of paragraphs.12-14, characterized in that it additionally contains caffeine mixed with NSAIDs elcetions acceptable excipients.

 

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