Medicinal preparation for treating proctological diseases

FIELD: medicine, proctology, pharmaceutics.

SUBSTANCE: the present innovation deals with obtaining medicinal forms as suppositories applied for treating proctological diseases. Medicinal preparation as suppositories containing active substance, anesthetic, purified water and foundation could additionally contain antiseptic and local irritating substance, as an active substance - glucocorticoid at the following ratio of components, weight%: glucocorticoid 0.0277-0.0368, anesthetic 1.8-2.2, antiseptic 2.8-3.52, local irritating substance 0.288-0.352, purified water 1.8-2.2, foundation - the rest. As glucocorticoid that inhibits the release of inflammation mediators and causes pronounced antiphlogistic and antiallergic action one should apply, for example, hydrocortisone or synaflane. As anesthetic one should apply, for example, anesthesin, lidocaine or trimecaine. As antiseptic being of astringent, drying off and analgesic actions one should apply, for example, dermatol or xeroform. As local irritating substance being of reflector, venotonic, analgesic and antiphlogistic and, also, antimicrobial actions one should apply, for example, racemic menthol or essential oils.

EFFECT: higher therapeutic efficiency.

5 cl, 3 ex, 4 tbl

 

The present invention relates to medicine, namely to the pharmaceutical industry, and can be used to produce dosage forms in the form of suppositories used for the treatment of proctologic diseases.

Known composition of the treatment of pain, rectal suppositories, protected by the RF patent №2102978, class a 61 K 9/02, publ. 1998.01.27.

Candles contain benzocaine, dermatol, zinc oxide, menthol, and as the basis of the polyethylene oxide 1500 and polyethylene oxide 400.

The tests known rectal suppositories of the above composition showed the effectiveness of their use only as an analgesic, antiseptic, disinfecting, drying and binders in the treatment of diseases of the rectum (cracks, itching, causes, hemorrhoids). In the treatment of such proctologic diseases such as acute thrombosis of the external and especially internal hemorrhoids, rectal known candles positive result does not give.

Known combination drug for the topical treatment of hemorrhoids and inflammatory diseases of the anus "Ultraproct"manufactured by Schering Germany (Register of medicines of Russia, M., 2003, page 856). In the preparation includes fluorinated glucocorticosteroid forcertain as quickly (pialat) and slow (caproate) absorbed derivatives and local anesthetic, zinho the Ayin (dibucaine).

The drug is expensive and its constituent components are not registered in Russia.

Known drug "Proctosedyl"containing tribenzoate and lidocaine (Register of medicines of Russia, encyclopedia of drugs, M., 2000, page 764).

The drug has insufficient drying, antiseptic and astringent properties.

Closest to the claimed technical essence and the achieved result, selected as a prototype, is a drug for the treatment of proctologic diseases, protected by the RF patent №2151592, class a 61 K 9/02, a 61 K 31/715, And 61 To 31/245, publ. 2000.06.27. Known drug in the form of suppositories contain the active ingredient, benzocaine, emulsifier, purified water and base. As active substances are used heparin in the number 0,006-0,01 g, basics - fat confectionery firm on the basis of hydrogenated fat or a mixture of mono-, di - and triglycerides of natural saturated fatty acids with carbon chain length of C12-C18to obtain suppository weight of 1.15-1,45,

Famous drug used by passive venous congestion of hemorrhoids, but it is not effective when other proctological diseases.

The problem solved by the invention, is expanding Arsenal of medicines for the treatment of proctologic dis is evani.

The technical result from the use of the invention is to improve therapeutic efficacy of a drug.

This result is achieved in that the medicinal product for the treatment of proctologic diseases in the form of suppositories containing the active substance, anesthetic, purified water, and the base further comprises an antiseptic and irritant agent, and as an active substance a glucocorticoid at the following content, wt.%:

glucocorticoid - 0,0277-0,0368

anesthetic - 1,8-2,2

antiseptic - 2,8-3,52

irritant agent - in 0.288-0,352

purified water - 1,8-2,2

base - the rest

As glucocorticoid, inhibiting the release of inflammatory mediators and have a marked anti-inflammatory and anti-allergic effect, can be used, for example, hydrocortisone or sinaflana. As an anesthetic can be used, for example, benzocaine, lidocaine or trimekain. As an antiseptic, with astringent, drying and analgesic effect, can be used, for example, dermatol or kseroforma. As irritant funds that have a reflex wendonside, analgesic and anti-inflammatory, as well as a slight antimicrobial activity, can the be used, for example, menthol racemic or essential oils. As the basis can be used, for example, witepsol with the addition of emulsifier - distilled monoglycerides, taken in an amount of 2-5%. Purified water is introduced into the composition of the medicinal product to obtain a homogeneous structure of the suppository.

The quantitative content of glucocorticoid should be 0,00034-0,00046 g, preferably 0.0004 g on the average mass of one suppository or to 0.032% by weight of the suppository; antiseptic - being 0.036-0,044 g, preferably 0.04 grams or 3.2%; irritant tools - 0,0036-0,0044 g, preferably 0.004 g, or 0.32 per cent; anesthetic - 0,0225-0,0275 g, preferably 0.025 g or 2%; purified water - 0,0225-0,0275 g, preferably 0.025 g or 2%; the basics - enough to get the suppository mass of 1.25 g±5%.

Suppositories prepared as follows. The base alloy with an emulsifier at a temperature of 70-72°s, then the alloy is stirred until a homogeneous state and filtered. Antiseptic and glucocorticoid mixed with part of the framework and grind the mixture to obtain a concentrate with the desired dispersion. Water purified is dissolved anesthetic. In the remaining basis dissolve irritant agent, stirred the mixture to obtain a clear solution, which is then successively under stirring enter the softened concentrate Antisept the ka and glucocorticoid and an aqueous solution of anesthetic. The mixture is stirred until homogeneous. The resulting homogeneous mass is poured into the cell from a polyvinylchloride film and cool, which further allows to obtain suppositories that meet the requirements of the State Pharmacopoeia, XI edition.

Below are examples of the manufacture of suppositories. As glucocorticoid in the examples used Sinaflana (Synaphlanum) - fluoqinolona acetate - 6α,9α-Debtor-16α,17α-isopropylidene-hydroxy-pregna-1,4-Dien-11β,21-diol-3,20-dione or 6α, 9α-debtor-16α-exepedition-16, 17 acetonide for FS 42-2498-93; as an antiseptic - dermatol - bismuth subgallate (Dihydroxy-(3,4,5-trihydroxybenzoate) Fund 42-0033025900. As an anesthetic used Tribeca - 2-(Diethylamino)-N-(2,4,6-trimetilfenil)ndimethylacetamide hydrochloride hemihydrate in FS 42-2390-92 as irritant tools used menthol racemic - 5 - (Methyl-2(-2-propyl)cyclohexanol on FS 42-1866-97. Purified water used by FS 42-2442-97; witepsol is a mixture of triglycerides of natural dietary fatty acids (C12-C18with a small amount of mono - and diglycerides of the same acids - THE No. 3-99; distilled monoglycerides - monoether of glycerol and higher fatty acids - THE 10-1197-95.

Example 1.

In pouring the homogenizer alloy 3,38 kg witepsol with 0,087 kg of monoglycerides at a temperature of 7° With, then the alloy is stirred until a homogeneous state and filtered. 0.120 kg of dermatol and 0,0012 kg sinaflana mixed with part of the framework and grind the mixture to obtain a concentrate with the desired dispersion of at least 95% to 40 μm. In 0,075 kg of purified water was dissolved 0,075 kg trimekainom. In the remaining basis dissolve 0,012 kg menthol at a temperature of 45°stir mixture to obtain a transparent solution. Then bring the temperature to 38-40°and the solution successively with stirring enter the softened concentrate dermatol with sinaflana, then at a temperature of 35-37°With an aqueous solution of trimekainom under stirring turbine agitator. The mixture is stirred until homogeneous. The resulting homogeneous mass is poured into the cell from a polyvinylchloride film and cool. Get suppositories weight of 1.25 g having the following composition:

sinaflana - 0.0004 g (0,032%)

dermatol - 0.04 g (3.2 per cent)

trimekain - 0,025 g (2%)

menthol - 0,004 grams (0.32 per cent)

purified water - 0,025 g (2%)

base - the rest

Example 2. Carried out analogously to example 1, but with the following quantities of components: Sinaflana - 0,00102 kg of dermatol - to 0.108 kg purified water - 0,0675 kg, trimekainom - 0,0675 kg menthol - 0,0108 kg, witepsol - 3,408 kg, distilled monoglycerides - 0,087 kg

Get suppositories weight of 1.25 g having the following composition:

sinaflana - 0,00034 g (0,0277%)

der is ATOL - 0.036 g (2.8 per cent)

trimekain - 0,0225 g (1.8 per cent)

menthol - 0,0036 g (in 0.288%)

purified water - 0,0225 g (1.8 per cent)

base - the rest

Example 3. Carried out analogously to example 1, but with the following quantities of components: Sinaflana - 0,00138 kg of dermatol - 0,132 kg purified water - 0,0825 kg, trimekainom - 0,0825 kg menthol - 0,0132 kg, witepsol - 3,352 kg, distilled monoglycerides - 0,086 kg Receive suppositories weight of 1.25 g having the following composition:

sinaflana - 0,0046 g (0,0368%)

dermatol - 0,044 g (3.52 per cent)

trimekain - 0,0275 g (2.2 per cent)

menthol - 0,0044 g (0,352%)

purified water - 0,0275 g (2.2 per cent)

base - the rest

Determination of sinaflana and trimekainom was performed by high performance liquid chromatography (HPLC), dermatol method of burning.

Test for microbiological purity suppositories obtained in examples 1-3, conducted by the global Fund XI, issue 2, pages 193-201, Change No. 1 from 28.12.95 (category 4). The following results were obtained: aerobic bacteria - 55, yeasts and moulds - 100, opportunistic missing.

Received suppositories have a light yellow color with a greenish hue and odor of menthol. In appearance suppositories satisfy the requirements of the global Fund XI, issue 2, page 151. Prototypes suppositories kept in a cool place, periodically checking their quality. Found that the best conditions the Oia storage suppositories not exceeding 20° Since, however, they retain their properties for 2 years.

Studies have been conducted to study the influence of physical factors, such as the action of air, light and temperature, obtained in examples 1-3 suppository mass. To determine the effect of air through suppozitornyj mass at a temperature of 40°maintains air for 7 hours, after which the mass was subjected to analysis. The results showed that the color of masses of examples 1-3 have not changed with the control sample. Analysis of the obtained data on the effects of light showed that the storage of mass-lit place even within 10 days does not change color masses in comparison with the control sample. To determine the effect of temperature samples suppozitornoj mass in examples 1-3 were subjected to the following temperatures: 40, 45, 50°C for 7, 14, 21, hours. After 7 hours taking samples suppozitornoj mass for analysis. The results showed that the color suppozitornyj mass was changed from exposure to temperatures ranging from 45°from light-yellow to light yellow with a brownish tinge. Thus, it was found that 45°C is the critical temperature, which is invalid in the manufacture suppozitornoj mass of the proposed structure.

Content sinaflana in one suppositories is defined therapeutic dose. The decrease is their number sinaflana less 0,0277% has no therapeutic effect, and an increase of more 0,0368% causes side effects. The increase in the number of dermatol more 3,52% technologically impractical, and a decrease of less than 2.8% - provides a soothing effect. When the amount of menthol less in 0.288% not achieved distracting effect, and when more than 0,352% may result in irritation. The increase in the number of trimekainom more than 2.2% technologically impractical, and a decrease of less than 1.8% does not provide an anesthetic effect. Increase the amount of water purified to more than 2.2% violates the manufacturability of the process, reduction of less than 1.8% does not provide solubility of trimekainom. The Foundation has physiological indifference, does not cause macroscopic and microscopic changes in local and General, in the body. Has good ability to release the drug substance from the basics. Adding emulsifier allows to obtain technologically stable suppozitornyj mass. If the content of monoglycerides less than 2.5%, the weight is heterogeneous, and if more than 3%, there are difficulties in the manufacture of suppositories, weight zapenivaetsya.

Thus, the choice of components and their quantitative values, you can obtain a new technical result - the creation of an effective anti-inflammatory, analgesic and antipruritic medicines in VI is e suppositories for the treatment of proctologic diseases.

Preclinical testing of suppositories were conducted to explore their potential allergenic, immunotoxic, embryotoxic, teratogenic and mutagenic properties. Limit the clinical application of the drug may be pregnancy and early age.

In clinical trials offered drugs in suppository above composition proved to be effective in the treatment of chronic hemorrhoids in stages I-II.

Below are examples of the clinical study experienced parties offer suppositories.

Clinical studies the efficacy and safety of suppositories was conducted on the basis of the state Scientific Center of Coloproctology health Ministry in 2003 between 21.02.2003, 27.04.2003, in consultation polyclinic of the state Scientific Center of Coloproctology health Ministry has received on the treatment of chronic and acute hemorrhoids the suppositories of the proposed structure 30 patients aged 22 to 58 years. Men was 11 (36.7 per cent), women - 19 (63.3 per cent). All patients diagnosed with chronic hemorrhoids I-II degree. Of these, 25 patients had evidence of acute thrombosis of external hemorrhoids, accompanied by swelling and redness of the nodes that were clinically consistent with stage I acute hemorrhoids. Anal fissure is Yavlena in 6 patients.

All patients had varying degrees of severity of pain, with severe pain were noted 9 (30%) patients, moderate pain was observed in 21 (70%) patients. Discomfort in the crotch area was observed in all patients. The itching in the anus complained all the patients, while the burning was noted on 28 subjects (93,3%). Virtually all patients have these symptoms were caused by defecation 67% in the sitting position and 23% when walking. Constipation suffered 15 patients (50%), rectal bleeding was noted 18 (60%) of subjects.

At external examination in the study group patients, 25 (83,3%) were enlarged, edematous external hemorrhoid ties from them hyperemia was observed in 16 (53.3 percent) patients. When breeding the edges of the anus anal fissure diagnosed in 6 (20%) patients, of whom one patient in the edges of the mucosal defect had cicatricial changes. If anoscopy the presence of enlarged internal hemorrhoids detected in 24 patients (80%)of them with eroded surface in 13 patients (43,3%).

All subjects were assigned to declare suppositories scheme - 1 suppository 1 time a day for 5 days, after which it exercised control the dynamics of the basic manifestations of the disease. If necessary, therapy continued up to 10 days. Evaluation of effectiveness was based on subjective felt the response note by the patient and objective reasons recorded by the attending physician. 30 patients receiving the proposed suppositories according to the described scheme, came up with the main group. The control group consisted of 27 patients aged 18 to 61 years, men - 13 (48.1 percent), women - 14 (51.9 percent), which was in outpatient treatment in consultative polyclinic of the State Scientific Center of Coloproctology MZ the Russian Federation from October to December 2002 and received drug treatment “PROCTOSEDYL” 1 suppository 3 times a day for 7 days.

Safety assessment of therapy investigational drug was carried out by recording adverse events, monitoring the performance of blood and urine tests, which were conducted twice during the study: before treatment and after its completion, each included in the study patient.

In the course of the study noted the high clinical efficacy of the study drug - rectal suppositories, in the case of most manifestations of the underlying disease. Dynamics of clinical manifestations of the disease when the drug use is presented in table 1, the dynamics of objective symptoms of acute and chronic hemorrhoids obtained during clinical studies, presented in table 2.

In therapy the tested preparation is that in 5 days the pain was cropped in 17 patients out of 30, the remaining 11 patients, this symptom disappeared in the process of further treatment.

Itching, which prior to treatment was noted by all 30 patients, was stopped within 5 days, 23 patients in the other 5 people complaints disappeared within the next 5 days of therapy.

The burning sensation that is felt 28 patients before the study began, it took 25 patients during the first 5 days, and in 1 patient during the remaining 5 days of therapy.

The presence of discomfort was noted by all 30 patients before therapy, the second visit (after 5 days of treatment with investigational drug) 19 patients were not noted discomfort, and at the end of the study, all patients reported no discomfort. Bleeding occurred in 18 patients before treatment, and only 1 patient with this symptom persisted on the 5th day of therapy; in the 10-day therapy of bleeding was not observed in any patient.

Heaviness in the perineum, which before therapy was reported by 12 patients, disappeared in all within 5 days of receiving the study drug. Swelling of the outer nodes defined in 25 patients before treatment, the second visit was gone in 13 patients and on the third visit was not determined in any patient. Hyperemia of external nodes detected in 16 patients during therapy was eliminated from all the of patients within 5 days of treatment.

Spasm of sphincter determined in 15 patients after 5 days of treatment, were found only in 1 patient, and at the end of the study none of the patients has not been detected. Erosion on the surface of internal hemorrhoids, recorded in 13 patients, epithelialize in the process of research in all 11 patients remaining in the study.

In evaluating the results of therapy with investigational drug, we used the following parameters:

The best result is the disappearance of all subjective (pain and burning in the anus and so on) and objective (swelling, redness nodes) manifestations of the disease are registered in 22 patients (73%).

Good - the reduction of all symptoms by 75%, was observed in 6 patients (20%).

So great and good effect of treatment with investigational drug was observed in 28 (93.3%of the patients included in the study.

Unsatisfactory result - increased burning and discomfort in 5-15 minutes after insertion of the suppository, was noted in 2 patients (6.6 percent). The appearance of these complaints regarded by researchers as adverse events that caused discontinuation of the drug before the end of clinical trials in these patients. The cause of the adverse events most likely is the idiosyncrasy of one or more components of drugs is a, as for the original parameters of subjective and objective criteria, these patients did not differ from the others in the study group (tables 1 and 2).

During clinical studies of changes in the parameters of blood and urine were noted.

When comparing the results of treatment in the two groups significant differences were received. Comparative characteristics of the dynamics of clinical manifestations of disease in the main and control groups are shown in table 3. Comparative characteristics of the dynamics of objective symptoms in the main and control groups are shown in table 4. It should be noted that to achieve the desired clinical effect of the drug “Proctosedyl” was used by patients 3 suppository per day for 7 days, at that time, as the study drug 1 suppository per day for 5 days in most patients, which led to the reduction of treatment costs and improve the quality of life of the patient.

Thus, tested in the clinic of the drug in the form of rectal suppositories can be effectively applied in the treatment of patients with I-II stage of chronic hemorrhoids, including complications of anal fissure, as well as in acute hemorrhoids first degree. The study drug at a dose of 1 suppository per day is effective against all clinical signs and objective symptom is acute and chronic hemorrhoids in stages I-II. Excellent and good effect of treatment with investigational drug registered in 28 patients (93,3%) included in the study patients.

When comparing the results of treatment in the two groups significant differences were received. It should be noted the high clinical efficacy of the study drug at a dose of 1 suppository per day)less than with standard drug therapy “Proctosedyl” (3 suppository per day), which reduces the cost of treatment and improves the quality of life of the patient.

During clinical studies of changes in the parameters of blood and urine were noted. All patients completed the study, was well tolerated therapy that indicates a high safety profile of the investigational product.

Clinical studies the efficacy and safety of the proposed drug in comparison with retrospective data using standard therapy (suppositories "Proctosedyl") in the treatment of chronic hemorrhoids in stages I-II were also employees of the Department of gastroenterology center for education and research Medical center office of the President of the Russian Federation on the basis of 51 CCH 18 February and 28 April 2003, When we compare the results of treatment with investigational drug and drug Proctosedyl" significant differences had been received, one is about, on the background of drug therapy "Proctosedyl" clinical effect was obtained when the drug is administered in a dose of 3 suppositories per day, whereas the study drug, patients received 1 suppository per day, which significantly improves the quality of life of patients. The disappearance of itching and burning in anus, General discomfort and other clinical manifestations of hemorrhoids was observed in all 29 patients. 2-3 days of treatment improvement occurred in 13 (43,3) patients, at 4-5 days of treatment in 14 patients (46,6) and in 2 patients (6,6) on the 7th day of treatment. Rapid relief of patient complaints indicates a high efficiency of the investigational product in relation to clinical manifestations of hemorrhoids. Adverse events associated with the use of the investigational drug was not, tolerability was good, the values of the blood and urine on the results of therapy with investigational drug did not significantly change, suggesting the safety of its application. The treatment results say about the viability and appropriateness of the study drug in the treatment of chronic hemorrhoids I-II degree.

Table No. 1.
Clinical manifestations of the diseaseVisit 0Visit 2* Visit 3
N=30%N=30%N=28*%
Pain30100%1136,6%0 
Itching30100%723,3%0 
Burning2893,3%310%0 
Tenesmus413,3%0-0 
Foreign body sensation1756,7%723,3%13,3%
Discomfort30100%1136,6%0 
Heaviness in the perineum1240%0-0 
Bleed1860%13,3%0 
* the 2nd visit in 2 patients experienced adverse events, expressed in increased burning in the anus with the drug, these patients are excluded the C further research.

Table No. 2.
Objective symptomsVisit 0Visit 2*Visit 3
N=30%N=30%N=28*%
Swelling of the outer nodes2583,3%1240%0-
Hyperemia of external nodes1653,3%0-0-
The mucosal defect without scarring516,6%0-0-
Spasm of sphincter1550%13,3%0-
The presence of internal nodes with eroded surface1343,3%26,6%0-
* on the 2nd visit 2 patients excluded from further study due to adverse events occurred

td align="center" namest="c4" nameend="c5"> 3 (11,1%)
Table No. 3
The wedge is ical manifestations of the disease Before treatmentAt the end of the treatment
The main group Islip. p=30The control group Proctosedyl p=27The main group Islip. p=28*The control group Proctosedyl n=26*
Pain30 (100%)27 (100%)00
Itching30 (100%)27 (100%)00
Burning28 (93,3%)24 (88,9%)00
Tenesmus4 (13,3%)not rated0not rated
Foreign body sensation17 (56,7%)16 (59,5%)1 (3,3%)2 (7,4%)
Discomfort30 (100%)27 (100%)02 (7,4%)
The severity of the perineum 12 (40%)14 (51,8%)00
Bleeding18 (60%)17 (62.9 per cent)02 (7,4%)
Table No. 4
Objective symptomsBefore treatmentAt the end of the treatment
The main group Islip. p=30The control group Proctosedyl p=27The main group of studies. drug n=28*The control group Proctosedyl n=26*
Swelling of the outer nodes24 (80%)27 (100%)01 (3,7%)
Hyperemia of external nodes16 (53.3 per cent)15 (55.6 per cent)00
The mucosal defect with scars1 (3,3%)000
The mucosal defect without scarring5 (16,6%)00
Spasm of sphincter15 (50%)18 (66,7%)00
The presence of internal nodes (eroded surface)13 (43,3%)15 (50%)02 (7,4%)
* Adverse events was noted in 2 patients of the main and 1 patient in the control group. These patients were excluded from the study.

1. Drug for the treatment of proctologic diseases in the form of suppositories containing the active substance, anesthetic, purified water and a base, characterized in that it additionally contains antiseptic and irritant agent, and as an active substance a glucocorticoid at the following content, wt.%:

glucocorticoid 0,0277-0,00368

anesthetic 1,8-2,2

antiseptic 2,8-3,52

irritant tool 2,88-3,52

purified water 1,8-2,2

the basis of the rest

2. The drug according to claim 1, characterized in that as glucocorticoid it contains hydrocortisone or sinaflana.

3. The drug according to claim 1, characterized in that as the anesthetic it contains benzocaine, lidocaine or trimekain.

4. The drug according to claim 1, characterized in that as an antiseptic it contains dermatol or kseroforma.

5. The drug according to claim 1, characterized in that as the irritant means it contains menthol racemic or essential oil.

6. The drug according to claim 1, characterized in that as the Foundation it contains witepsol with the addition of emulsifier - distilled monoglycerides, taken in an amount of 2-5%.



 

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2 cl

FIELD: medicine, gynecology, pharmacology, pharmaceutical industry.

SUBSTANCE: invention proposes a preparation that comprises bacterial mass of live microorganisms as an active component, protecting medium and fat base. The preparation comprises lactobacilli as bacterial mass and one or some eubiotic microorganisms taken among the following group: bifidobacteria, streptococci and lactococci taken in the amount per a single dose. Also, the preparation comprises additionally an acceptable sorbent and a biologically active supplement. Also, invention relates to a method for preparing this preparation that involves preparing firstly lactobacilli bacterial mass and one or some genus of eubiotic microorganisms taken among the following group: bifidobacteria, streptococci and lactococci. Then the prepared bacterial mass of microorganisms is immobilized on sorbent used in medicine in its ratio to bacterial mass of microorganisms = (9-1):(1-9) followed by addition of the protecting medium and biologically active supplement to formed mass in the necessary amount. Also, invention describes a method for prophylaxis and treatment of bacterial vaginitis that involves intravaginal administration of the preparation described above in the amount 1-3 doses, 1-3 times per 24 h. The treatment course is prescribed individually. Invention provides expanding assortment of agents used for treatment of bacterial vaginitis. Invention can be used in obstetric-gynecological practice.

EFFECT: improved method for vaginitis treatment, valuable medicinal properties of preparation.

13 cl, 4 tbl, 1 ex

FIELD: pharmaceutical industry.

SUBSTANCE: rectal- and vaginal-administration suppositories contain 1,3-diethylbenzimidazolium triiodide as active principal, polyvinylpyrrolidone as solubilizer and stabilizer, and lipophilic base with specified proportions of components.

EFFECT: extended therapeutical activity and reduced occurrence of side effects.

4 cl, 2 ex

FIELD: chemical and pharmaceutical industry.

SUBSTANCE: the present innovation deals with creating medicinal preparations of plant origin and could be applied for treating functional constipations and affected biorhythm of defecation. It is suggested to apply either dry aqueous or aqueous-alcoholic extract of horse chestnut seeds of Aesculus species to prepare curative-prophylactic preparation in case of constipation and affected biorhythm of defecation. The suggested preparation should be applied in the form of powder, tablets or suppositories. Pharmaceutical composition for preventing and treating constipation and affected biorhythm of defecation contains an active substance out of medicinal plant and a pharmaceutically acceptable filling agent, moreover, this preparation is designed as suppositories and contains either dry aqueous or aqueous-alcoholic extract of horse chestnut seeds of Aesculus species and suppository hydrophobic foundation at certain content of ingredients. Dry aqueous or aqueous-alcoholic extract contains 1-50% active substance as escin. As foundation it could contain either cacao oil or vitepsol. The method for preventing and treating constipations and affected biorhythm of defecation deals with introducing the suggested pharmaceutical composition into patient's anus 5-15 min before planned act of defecation. Application of "Rectum-activ" preparation provides positive result at treating functional psychogenic constipation: in 5-15 min after introducing a suppository into anus pronounced urgency for defecation. In case of course therapy for 4 wk one should observe restoration of natural urgency for intestinal evacuation. Moreover, purgative preparation causes no unfavorable pain feelings.

EFFECT: higher efficiency.

10 cl, 6 ex

The invention relates to medicine and can be used in proctology, urology, obstetrics and gynecology, Pediatrics, gastroenterology, Oncology, therapy, surgery, etc

The invention relates to compositions and methods for the treatment and prevention of such diseases and conditions as graft rejection, surgical adhesions, inflammatory bowel disease, nasal polyps, and includes delivery to the site of inflammation antimicrotubular agent is paclitaxel, or an analogue or derivative
The invention relates to the field of pharmaceutics and can be used in the treatment of prostatitis
The invention relates to the field of pharmaceutical industry and relates to vaginalnyj suppositories for the treatment of imperative incontinence urination

The invention relates to the field of veterinary obstetrics

FIELD: chemical and pharmaceutical industry.

SUBSTANCE: the present innovation deals with creating medicinal preparations of plant origin and could be applied for treating functional constipations and affected biorhythm of defecation. It is suggested to apply either dry aqueous or aqueous-alcoholic extract of horse chestnut seeds of Aesculus species to prepare curative-prophylactic preparation in case of constipation and affected biorhythm of defecation. The suggested preparation should be applied in the form of powder, tablets or suppositories. Pharmaceutical composition for preventing and treating constipation and affected biorhythm of defecation contains an active substance out of medicinal plant and a pharmaceutically acceptable filling agent, moreover, this preparation is designed as suppositories and contains either dry aqueous or aqueous-alcoholic extract of horse chestnut seeds of Aesculus species and suppository hydrophobic foundation at certain content of ingredients. Dry aqueous or aqueous-alcoholic extract contains 1-50% active substance as escin. As foundation it could contain either cacao oil or vitepsol. The method for preventing and treating constipations and affected biorhythm of defecation deals with introducing the suggested pharmaceutical composition into patient's anus 5-15 min before planned act of defecation. Application of "Rectum-activ" preparation provides positive result at treating functional psychogenic constipation: in 5-15 min after introducing a suppository into anus pronounced urgency for defecation. In case of course therapy for 4 wk one should observe restoration of natural urgency for intestinal evacuation. Moreover, purgative preparation causes no unfavorable pain feelings.

EFFECT: higher efficiency.

10 cl, 6 ex

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