Preparation polykatan

FIELD: medicine.

SUBSTANCE: invention refers to pharmaceutical industry and represents a preparation possessing the anti-inflammatory action, stimulating the mucosa regeneration, and containing magnesium-chloride mineral bischofit brine 1.27±0.01 g/ml with normalised specific gravity, slastiline, menthol, thymol, and a stabilising agent differing by the fact that it contains magnesium-chloride mineral bischofit brine free from technogenic impurities, with the ingredients in the preparation are taken in specific proportions, g.

EFFECT: reducing acute daily oral toxicity in 1,7-1,9 times.

1 tbl

 

The invention relates to the field of medicine, new medicines, exhibiting anti-inflammatory, antimicrobial, wound healing and stimulating phagocytosis action.

It is widely known and used in the clinical practice of medicine "Policeman", which are standardized by the specific gravity of 1.27±0.01 g/ml of brine chlorimines mineral bischofite, optionally containing corrector taste slastion, antiseptics menthol and thymol, stabilizer tween-80 or gelatos [RF Patent №2053774 (1996). Spasov AA, Temkin ES, O. Ostrovski, Skorokhodova E.N., Vdovin G.P., Perevozchikov GG, Gerchikov L.N., Borovsky E.V., Ermakov VA // Drug having anti-inflammatory and stimulating regenerative processes in the mucous membranes of the action (AC 33/00) / bul. Fig. - 1996. No. 4]. Shown high efficiency of application of Polycatan in dental practice, dermatology in inflammatory diseases of the upper respiratory tract, sensorineural hearing loss, hypertension and other diseases [Spasov AA Magnesium in clinical practice. - Volgograd: Publishing House. LLC "Lad", 2000. - 272].

Mineral bischofite is a uranyl magnesium chloride formula MgCl2×6H2O Deposit discovered large areas of the Caspian is hollow and Volga monocline at depths of 1000-2000 m Industrial production bischofite is produced by the method of underground vysalivaniya that allows you to extract 75-85%bischofite brine. The resulting brine is diluted with water to the required concentration and standardize density. However, the presence of a number of natural and man-made impurities in the solution of bischofite significantly limits its medical use. Developed drug and Spa facilities on the basis of bischofite, including "Balikatan, only apply topically in the form of mouthwashes, baths, compresses, solutions for electrophoresis, ointments, liniments, pastes, or patches. Impurities included in the bischofite include the salts associated alkaline earth metals (beryllium, calcium, barium), iron and heavy metals [Spasov AA, Orobinskaya T.A., L.A. Smirnova // Success Fiziol. Sciences. - 1997. - So 28. - V.2. - S-93]. In addition, iron is the most significant man-made mixture as a product of corrosion of steel reinforcement wells. A particularly large impact on the quality of bischofite have impurities of petroleum products, which are mandatory auxiliary component in the production of bischofite and pumped into the well. In this regard, the application of bischofite as the basis for drugs used orally, without additional deep cleaning is impossible.

The development of otany our earlier method of purification of bischofite [RF Patent №2442593 (2012). Petrov V.I., Spasov AA, Ozerov A.A., sysouev B.B. // cleaning Method bischofite (AC 33/14, 01F 5/00, SW 1/00) / bul. Fig. - 2012. No. 5] provides a significant decrease in the content of iron and other impurities. This allows you to create based on purified bischofite new drug and Spa tools, including for enteral application.

The purpose of the proposed invention is the development of medicines "Policeman"with less toxicity and suitable for oral administration.

The invention consists in the use of brine chlorimines mineral bischofite, free from man-made impurities, to obtain drugs "Policeman".

To conduct Toxicological studies have been made in accordance with [RF Patent №2053774 (1996). Spasov AA, Temkin ES, O. Ostrovski, Skorokhodova E.N., Vdovin G.P., Perevozchikov GG, Gerchikov L.N., Borovsky E.V., Ermakov VA // Drug having anti-inflammatory and stimulating regenerative processes in the mucous membranes of the action (AC 33/00) / bul. Fig. - 1996. No. 4] samples of the medicinal product "Balikatan" based on purified and unpurified bischofite with the same quantitative composition:

Brine mi is erala bischofite (density of 1.27±0.01 g/ml) - 100
Slastion (aspartame, E 951)- 0,01
Menthol- 0,005
Thymol- 0,005
Stabilizer (tween 80)- is 0.0002

The definition of acute daily toxicity of the proposed medicinal product "Balikatan" based on purified brine mineral bischofite, and known means "Policeman", produced from the crude brine mineral bischofite, were performed in the laboratory of medicinal safety research Institute of pharmacology, Volgograd state medical University. The experiments were performed on rats of both sexes, which investigational drugs were administered intragastrically in various doses in accordance with [Manual on experimental (preclinical) study of new pharmacological substances", Ed. Rugarama. - Ed. 2. - M.: JSC "Publishing house "Medicine", 2005. - 832]. It is established that the death of animals was recorded after the introduction of them "Balikatan" based on purified bischofite in the dose range from 4.0 to 9.5 ml/kg, and the introduction of Polycatan" based on crude bischofite in doses ranging from 2.0 to 6.0 ml/kg per animal. The magnitude of LD50 at the same time slightly differed for female rats and rats-males (table 1).

Table 1.
Sharp daily toxicity of the medicinal product "Balikatan" after intragastric administration
№ p/pMedicationAcute toxicity, LD50ml/kg
Rats-femalesRats-males
1"Balikatan" based on purified bischofite6,30(4,95-8,65)7,20(5,86-9,05)
2"Balikatan" based on crude bischofite3,79(2,85-4,95)3,72(3,05-4,59)

For clinic manifestations of toxic effects was characterized by the presence of sedation, inhibition of mobility, breathing, muscle relaxation, reduction in body temperature, reactions to pain and audio stimuli. These signs occurred in animals mainly after the introduction of Polycatan" after 10-15 min in toxic doses. Death was preceded by tonic twitching limbs, lateral position, sudden respiratory depression. The death of the animals ü noted in the first day during the first 4 hours of observations. The restoration of the physical and behavioral activity in animals that remained alive were observed at the end of the second day of observations. In subsequent timing observations of mortality were noted. According to the results of the registration of the dynamics of body weight of the rats was recorded decrease in weight gain in the experimental animals (on average by 10% in comparison with control) in the first week and gradually restore it to the end of the 2-week observation period.

Thus, the use of brine chlorimines mineral bischofite, free from man-made impurities, to obtain drugs "Balikatan allows 1.7-1.9 times lower acute toxicity of the drug compared with Polycatenar", obtained on the basis of the crude bischofite.

Drug, has anti-inflammatory and stimulating regenerative processes in the mucous membranes of the action, containing standardized by the specific gravity of 1.27±0.01 g/ml of brine chlorimines mineral bischofite, slastion, menthol, thymol and stabilizer, characterized in that it contains brine chlorimines mineral bischofite, free from man-made impurities, in the following ratio of components, g:

brine chlorimines mineral bischofite 100
slastion0,01
menthol0,005
thymol0,005
stabilizeris 0.0002



 

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