Rectal suppositories containing vitamin complex

 

(57) Abstract:

The invention relates to medicine, more specifically to a drug in a form representing a suppository containing vitamin complex. The invention consists in that the composition contains pyridoxine hydrochloride (Vit. B6), cyanocobalamin (Vit. B12) and suppozitornyj based on a certain ratio of the components on one candle mass of 1.27-1,41, the Invention provides the creation of medicines in the form of suppositories, which has high biological activity, the ease of use and has no side effects. table 2.

The invention relates to the field of medicine, but rather a drug in a form representing a suppository containing vitamin complex.

The invention can most effectively be used as a medicine in the form of a suppository (candles) for the treatment of diseases that lead to violations of the membrane structure of cells and their organelles (acute tissue hypoxia, acute bacterial and viral infections, chronic somatic diseases in the acute stage, allergic reactions, anemia), as a means of influencing tissue is the treatment and as an adjunct to standard treatment.

Known drug in the form of tablets, coated (pantovic) [1] with the property to provide a therapeutic effect in diseases of the peripheral and Central nervous system and contains:

Thiamine chloride 0.01 g (Vit. B1)

Pyridoxine hydrochloride, 0.005 g (Vit. B6)

Cyanocobalamin - 0.00005 g (Vit. B12)

Nicotinamide - 0.02 g

Folic acid - 0.03 g (Vit. Sun)

Since this composition is presented in tablet form, it is not suitable for the treatment of children with neonatal period, infancy and early age, for patients with impaired function of the gastrointestinal tract (intestinal dysbiosis, gastritis).

Known medicinal composition - pills "Decemeber" [2] , coated, containing:

Retinol - 0.00227 g (ME) (Vit. A)

Thiamine chloride and 0.02 g (Vit. B1)

Riboflavin - 0.01 g (Vit. B2)

Pyridoxine hydrochloride, 0.02 g (Vit. B6)

Cyanocobalamin - 0.0001 g (Vit. 12)

Folic acid - 0.005 g (Vit. Sun)

Rutin - 0.02 g (Vit. P)

Tocopherol acetate - 0.01 g (Vit. E)

Methionine - 0.2 g

Ascorbic acid - 0.2 g (Vit. C)

Nicotinamide - 0.05 g

However, this composition is also not suitable for children neonatal period, Grodno is. the moreover, advanced ingredients of this composition are capable of causing allergic reactions in immunocompromised patient population.

Known medicinal composition (solution for injection) "Neurexin-12" [3] , which contains:

Thiamine chloride 0.03 g (Vit. B1)

Pyridoxine hydrochloride - 0.01375 g (Vit. B6)

Cyanocobalamin - 0.0005, (Vit. B12)

This composition is chosen as a prototype as the closest analogue of the present invention to the technical essence and the achieved effect. Composition "Neurexin-12" recommended for the treatment of diseases of the peripheral nervous system.

However, this arrangement is inconvenient for independent use, as is used in the form of intramuscular injections. For the children from the neonatal period, infancy and early age the use of this composition is undesirable, because it is accompanied by pain effect, which reduces the effect of the treatment.

The present invention is the creation of medicines in the form of suppositories, affecting tissue metabolism, easy to use and has no side effects.

The problem is solved in that the claimed suppository again in the following ratio of components on one candle weighing 1.27-1.41 g (g):

Pyridoxine hydrochloride - 0.016-0.024

Cyanocobalamin - 0.00008-0.00012

Suppozitornyj the basis of the Rest.

The claimed medicinal product in the form of suppositories has high biological activity, the ease of use and has no side effects.

As a medicinal components suppository contains:

1. Pyridoxine hydrochloride (Vitamin B6) (HFH, senior 566) - 2 - Methyl-3-hydroxy-4,5-di-(oxymethyl) pyridine hydrochloride. White crystalline powder, odorless, bitter-sour taste. Pyridoxine hydrochloride plays an important role in metabolism. It is necessary for the normal functioning of the Central and peripheral nervous system, it is part of the enzymes involved decarboxylation and transamination of amino acids. It plays an important role in the metabolism of histamine. Involved in the processes of fat metabolism. Practically non-toxic. Using pyridoxine in various diseases: when toxemia of pregnancy, anemia, nervous system diseases, acute and chronic hepatitis, dermatitis, allergic diathesis, etc.

2. Cyanocobalamin (Vitamin b 12) (HFH, senior 1921) - -(5,6-dimethylbenzimidazolyl) cyanocobalmin. This crystal is steadily increasing. Is a growth factor necessary for normal blood formation and maturation of red blood cells, contributes to the accumulation of compounds of sulfhydryl groups. Has a beneficial effect on liver function and the nervous system, on the metabolism of carbohydrates and lipids.

Pyridoxine hydrochloride (B6) and cyanocobalamin (B12) involved in the synthesis of heme of hemoglobin, restore impaired intracellular metabolism, are involved in metabolic regulation of lipids, stabilize cell membranes. They normalize the redox processes in cells, performing coenzyme functions.

3. As suppozitornoj bases use cocoa butter, tallow type a, Witepsol.

Cocoa butter (the State Pharmacopoeia - GFH Art. ) - fatty oil obtained by pressing roasted and released from the peel of cacao seeds. Dense homogeneous mass of yellowish color, sabarmathi smell of cocoa and a pleasant taste, brittle at room temperature, melts at 30-34oS, becoming transparent liquid, an acid number of not more than 2.25, iodine 32-38.

Tallow, type a (VFS 42-W-97) is a confectionery fat, firm-based plasticized hydrogenated fat from below the temperature 34-36oS, becoming transparent liquid, density 0.920-0.950. The pour point of not lower than 30oWith, an acid number of not more than 0.3.

Witepsol (ND 9584-98) is a mixture of triglycerides of natural dietary fatty acids12-C18with a small amount of mono - and diglycerides of the same acids. This homogeneous fat-like mass of white with a weak smell. In the molten state is transparent. The melting point of 33.5-35.5oWith temperature hardening 27-30oWith, iodine number not greater than 3, the acid is not more than 0.3.

Doses of drugs were chosen on the basis of doses in injectable dosage forms. The spacing of the components is selected according to the Order of the RF Ministry of health 305 dated 16.10.97 "On the norms of tolerance in the manufacture of pharmaceuticals and packaging of industrial products at the drugstore."

The decrease in the specified amount of pyridoxine hydrochloride does not lead to the manifestation of therapeutic effect, the increase may lead to undesirable side effects: worsening of liver function, increased diuresis, enhancing the action of diuretics allergic reactions.

Reducing the dose of cyanocobalamin does not proyavlena the STI heart tachycardia.

Number basis for medicines offered 1.27-1.41, studies have shown that increasing the number of bases slows down the release of active substances from suppositories and therefore may slow down the healing effect. Decrease the basis of less than 1.27 g leads to an increase in the concentration of the medicinal substance in the medicinal product, which can have a toxic effect.

The composition is prepared as follows. The required number of medicinal substances in the form of powders are mixed, following the rules of mixing powders (GFH 1, vol. 2, S. 150). The resulting mixture was triturated with a small amount of molten basics, introducing the remaining portion of the fused bases of the fractional portions and stirred to obtain a homogeneous mass. Received suppozitornyj mass is filtered and fed to the machine for the manufacture of suppositories. The masses poured into the cell from a film of polyvinyl chloride (type EP-73) at 32-34oC and cooled at a temperature of 5-10oC.

Suppositories pink, odorless, torpedo-shaped form. Each candle has a mass of 1.34, Physico-chemical characteristics of the suppository is presented in table 1.

Table 2 shows examples of specific compounds of the proposed suppositories.

The use of the claimed composition allows to obtain a dosage form - suppositories with therapeutic properties for the treatment of perinatal encephalopathy, acute respiratory disease, pneumonia, anemia, allergic reactions, diseases of the peripheral nervous system, disorders of metabolism.

The proposed dosage form is a suppository, containing a complex of vitamins B6 and B12, in the country and abroad are missing. In comparison with existing analogues - coated tablets, suppositories possess high biological availability, ease of use, can be used with increased gag reflex when malabsorption in the gastrointestinal tract. Moreover, with the introduction of rectal able to eliminate or significantly reduce presystemic to yaccino form (prototype) application of suppositories painless, does not cause degeneration of the endothelium of blood vessels, necrosis, tissue fusion, severe allergic reactions, anaphylactic shock and allergic dermatitis. An important advantage of suppositories is the compatibility of all incoming ingredients, the mixture menuitemindex injection before their introduction may lead to undesirable consequences.

The list of references.

1. Register of medicines of Russia. Encyclopedia of drugs. 6th edition, Moscow, RLS-2000", 1999, S. 645.

2. Drugs in Russia. Reference Vidal, 1998 , section b , C. 166.

3. Drugs in Russia. Reference Vidal, 1998 , section B. , S. 387.

Rectal suppositories containing vitamin complex and suppozitornyj base, characterized in that as vitamins suppository contains pyridoxine hydrochloride and cyanocobalamin in the following ratio of components on one candle mass of 1.27-of 1.41 g, g:

Pyridoxine hydrochloride - 0,016 - 0,024

Cyanocobalamin - 0,00008 - 0,00012

Suppozitornyj basis - the Rest

 

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