Psychotropic drug

 

(57) Abstract:

The invention relates to medicine, namely the creation of medicines used in psychiatric and neurological practice for the treatment of neurotic and neurosis-like States, as well as chronic alcoholism. The invention lies in the fact that psychotropic agent comprises as an active ingredient 4-hydroxybutyrate calcium in an amount of 0.1 to 0.5, alternatively, it may be in the form of tablets, capsules, powder and water solution. Made in the form of pills as an auxiliary substances it contains starch, calcium stearinovokisly, polyvinylpyrrolidone and talc at a ratio of components. The invention provides an effective medication without harmful side effects. 3 C. p. F.-ly.

The invention relates to the field of medicine and for the creation of medicines used in psychiatric and neurological practice for the treatment of neurotic and neurosis-like States, as well as chronic alcoholism.

For treatment of these conditions apply various means, among which the most commonly used anxiolytics benzodiazepine is t, piracetam and other (M. D. Mashkovsky. Medicines, 1993, 1 o'clock, M.: Medicine, 88-95 C., 131-142).

However, the impact of these drugs do not always achieve the desired effect and, in addition, in the case of benzodiazepines causes serious side effects (addiction, drug dependence, withdrawal syndrome, allergic reactions) (M. D. Mashkovsky. Medicines, 1993, 1 o'clock, M.: Medicine, S. 87).

In the treatment of chronic alcoholism is often used nootropic drugs from the group of derivatives of GABA, however, their use is limited to a narrow range of indications, and therefore it is often necessary combinations thereof with other agents (P. D. Shabanov, S. Y. Klishevich. The biology of alcoholism. SPb.: DOE, 1998, S. 190).

Know the use of 4-hydroxybutyrate sodium (sodium oxybutyrate) with neurotic and neurosis-like disorders, and also to suppress withdrawal symptoms in patients with chronic alcoholism. However, its practical use for these indications is limited due to the lack of tabloids, due to the high hygroscopicity of the substance 4-hydroxybutyrate sodium (centuries Zakusov (as amended). Sodium oxybutyrate. Neuropharmacological and Kleene is to use the drug orally. In addition, injecting 4-hydroxybutyrate sodium cause adverse effects: euphoria, nausea, vomiting, respiratory disorders, convulsive twitching of the limbs and tongue. In this regard, 4-hydroxybutyrate sodium in practice not applied for the treatment of patients with neurotic disorders and chronic alcoholism, and use only for reingestion anesthesia.

The present invention is the creation of an effective drug for the treatment of neurotic and neurosis-like States, as well as chronic alcoholism with astenodepressivnyh and asteno vegetative symptoms without harmful side effects.

The proposed psychotropic drug for oral administration comprising as an active ingredient 4-hydroxybutyrate calcium (patent UK 922029) in an amount of 0.1 to 0.5, alternatively, it may be in the form of tablets, capsules, powder and water solution. Made in the form of tablets, it is as excipients contains starch, calcium stearinovokisly, polyvinylpyrrolidone and talc in the following ratio, wt.%:

4-Hydroxybutyrate calcium - 80-90

Calcium, stearine is used for the treatment of neurotic, neurosis-like disorders or chronic alcoholism. The product has low acute and chronic toxicity and has no teratogenic or embryotoxic effects. LD50when enteral administration to mice is 1915 mg/kg

Declared the drug has been studied in the clinic for volunteers.

Example 1. Treatment of 11 people, whose condition was characterized by the presence in their mental status of a variety of disorders neurotic character. Significant place in the structure of mental pathology occupied wegetosomaticalkie disorders. Presenters were astenodepressivnyh and asteno vegetative syndromes. The drug was administered at doses of 1.0, 1.5 and 2.0 g per day. The duration of treatment ranged from 2 to 3 weeks. therapeutic effect of the drug was observed in General in all patients except one case. A marked improvement, manifested in the almost complete disappearance of mental disorders or significant reduction was noted in 4 cases. A moderate improvement in the form of a clear reduction of symptoms in General to a level less pronounced disorders was noted in 3 patients. In the remaining 3 observations gave positive therapy and developed gradually, reaching a maximum of 14-17 day, after which experienced a gradual stabilization. Tolerability of the drug, with the exception of one observation was good. At his reception was not observed allergic reactions, the drug did not cause drowsiness, weakness, or any other adverse and unwanted effects.

Thus, the drug was most effective against symptoms for weakness of character in asthenic, asthenoneurotic and astenodepressivnyh state of neurotic level in the framework of psychogenic and organic diseases of the Central nervous system.

Example 2. The treatment of patients with chronic alcoholism stage II - men from 25 to 60 years 55 people edema alcohol-withdrawal syndrome. The disease duration ranged from 5 to 20 years. The patients took the drug before meals 3-4 times a day. The maximum single dose is 0.5 to 1 g, the duration of treatment 14 days. The drug has a positive therapeutic effect. The phenomenon of abstinence was reduced 2-3 days after admission to the clinic, while no drug the sickness lasted much longer.

After the first dose of the drug after 20-30 min is te, experienced improved sleep. After two weeks of vascular-vegetative disorders continued, craving for alcohol weakened. It was noted to reduce the emotional tension.

The results of the study showed that the drug has a positive effect on asthenic, astenodepressivnyh, neurotic and somatovegetative disorders. During the first 3-4 days were stopped sleep disturbances, tremor, anxiety. Most patients have weakened the effects of stress, decreased craving for alcohol.

Feature of the product is the absence of drug dependency and muscle relaxant effect, it can be used for a long time both in the inpatient and outpatient settings.

Thus, the drug is an effective means of control recurrences attraction to alcohol and treatment astenodepressivnyh disorders in patients with chronic alcoholism.

The drug is recommended Pharmacological Committee of Ministry of health of the Russian Federation to the widespread medical use in the treatment of patients with various neurotic and neurosis-like disorders of various origins, as well as in the treatment of chronic alcoholism, etc>1. Psychotropic drug for oral administration, comprising the active ingredient and excipients, characterized in that the active ingredient it contains a 4-hydroxybutyrate calcium in an amount of 0.1 to 0.5 g

2. Psychotropic drug under item 1, characterized in that it can be made in the form of tablets, capsules, powder and water solution.

3. A psychotropic drug on PP. 1 and 2, characterized in that it is made in the form of tablets and as excipients contains starch, calcium stearinovokisly, polyvinylpyrrolidine and talc in the following ratio, wt. %:

4-Hydroxybutyrate calcium - 80-90

Calcium stearinovokisly - 1-2

Polyvinylpyrrolidone - 2-3

Talc - 1-2

Starch - Rest

4. A psychotropic drug on PP. 1-3, characterized in that it can be used for treatment of neurotic, nervous disorders or chronic alcoholism.

 

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