Gynaecological capsules (egg-shaped vaginal suppositories) for integrated treatment of postabortion endometritis

FIELD: medicine.

SUBSTANCE: presented egg-shaped vaginal suppositories contains the following mass ratio in 1 capsule (egg-shaped vaginal suppository): sulphadimine 0.05 g; metronidazole 0.01 g, potato starch 0.02 g, glucose 0.04 g, 5% polyvinyl alcohol 0.07 g, 15% oily extract of propolis 1.0 g; gelatine 0.2 g; dimethicone 0.04 g; glycerol 0.4 g; purified water 0.37 g.

EFFECT: using the invention increases the therapeutic effect and bioavailability of the capsules, increases the prolonged action time, provides the control release of the active substances.

3 cl, 1 dwg, 1 tbl, 3 ex

 

The present invention relates to the field of medicine, namely to pharmaceutics and concerns the development of medical capsules (egg-shaped vaginal suppositories) containing metronidazole, sulfadimezin and propolis extract oil, and can be used in complex treatment of chronic post-abortion endometritis, and other inflammatory diseases of female genital sphere.

Known suppositories Lactobacterin and allatom obtained on the basis of dry lyophilized biomass [Sharipov, I. S., Sergounin V. I., E. L. Krasinski, etc. Evaluation of therapeutic and prophylactic action candles with Lactobacterin on the microbiocenosis of children. IMEI. - 6. - 1993. - pp. 30-31.]. Suppositories are used to treat infectious and inflammatory gynecological diseases associated with microflora imbalance.

Famous liniment of Chloromycetin 1%, 5% and 10%, containing antibacterial active substance chloramphenicol ointment and the base containing castor oil, emulsifier No. 1, hydroxystearic of macrogolglycerol, sorbic acid, sodium carmelose, purified water, used for the treatment and prevention of infectious-inflammatory diseases in surgery, dermatology and obstetrics and gynecology [Mashkovsky M. D. Medicines. 4.2. - M.: Medicine, 1993. - pp. 303-304].

Known drug in the form of an ointment containing�e bisulfate and dioxidine, for a comprehensive treatment of infectious and inflammatory gynecological diseases as an anti-inflammatory, antimicrobial, stimulating the regeneration of the funds with the effect of prolongation [patent RU No. 2436567, 2011].

Known agent for the treatment of noninflammatory and inflammatory diseases of female pelvic organs, including complications of purulent-inflammatory processes, in the form of vaginal suppositories containing the active substance 2-ethyl-6-methyl-3-hydroxypyridine succinate and a base selected from the group: polyethylene oxide 1500, polyethylene oxide 400, cacao butter, hydrogenated fats [patent RU 2293558, 2007]. The invention provides extended release of a therapeutic drug in the mucosa and soft tissues and provides the effect for about 12 hours, while the procedure itself is comfortable and easy to perform and can be performed by patients themselves on an outpatient basis.

Known suppositories for the treatment and/or prophylaxis of gynecological diseases, characterized by the fact that the active substance they contain a pharmaceutical composition comprising propolis, naphtha, essential oils of calendula, Hypericum, eucalyptus, cedarwood, tea tree, sea buckthorn and acetate of tocopherol, extracts of tomato fruits, black raisin, licorice, periwinkle, padmanand�ka, calendula and TUI at a certain ratio, and as the basis they contain cocoa butter or solid fat [application RU # 2006132907, publ. 2008].

Known suppositories for the treatment and/or prophylaxis of gynecological diseases, characterized by the fact that the active substance they contain a pharmaceutical composition comprising the extract larvae big wax moth and propolis extract [patent RU No. 2429867, 2011].

The prototype of the invention are of gynecological ovule for complex treatment of inflammatory diseases of female genital sphere, made in the form of a capsule comprising gelatin, glycerin and purified water weighing 2.5 g and containing as active ingredients BHT and oil extract of propolis 15% [patent RU 2249449, 2005]. The invention provides receiving funds dosed with prolonged regenerating and anti-bacterial, comfortable and hygienic to use.

The object of the invention is to expand the Arsenal dosed medicines of domestic production in the form of capsules (egg-shaped vaginal suppositories), possessing anti-inflammatory, regenerating and antibacterial action, controlled release, suitable for use by patients on their own, with a pronounced and prolonged action Le�artenova funds.

The technical result - improving therapeutic effect and bioavailability, increase in prolonged action, controlled release of active substances.

Said technical result is achieved in that the means for the integrated treatment of chronic post-abortion endometritis, pelvic inflammatory disease, made in the form of a capsule (egg-shaped vaginal suppositories) containing the active ingredient oil extract of propolis (WEP) 15%, as the shell of gelatin, glycerin and purified water, according to the invention additionally contains as active ingredients sulfadimezin and metronidazole in the form of granules, as auxiliary substances dispersed phase comprising the suspended eccipienti, 5% polyvinyl alcohol (PVA), potato starch and glucose, and as the shell of the capsule Dimethicone, with the following ratio of components, g per 1 capsule:

Metronidazole0,01
Sulfadimezin0,05
Glucose0,04
Starch0,02
PVA 5%0,07
MEP 15%1,0
Gelatin0,2
Glycerin0,4
Dimethicone0,04
Purified water0,37

As the solvent, an oil extract of propolis contains vegetable oil, and as the solvent, the polyvinyl alcohol contains water purified.

The invention is illustrated in the following materials: the figure shows the kinetics of solubility capsules (egg-shaped vaginal suppositories) with metronidazole, sulfadimezin and oil extract of propolis in the model system (pH 4.5-5.0) in comparison with the prototype - capsules (ovulate) with BHT and oil extract of propolis, where: 1 - the solubility of capsules (egg-shaped vaginal suppositories) with metronidazole, sulfadimezin and oil extract of propolis in the model system; 2 - the solubility of capsules (egg-shaped vaginal suppositories) with BHT and oil extract of propolis in the model system; table - antibacterial activity of excipient with metronidazole, sulfadimezin and oil extract of propolis.

All components included in the SOS�AB capsules (egg-shaped vaginal suppositories), permitted for medical use. Medical gelatin GF X, 309. Glycerin FS 42-2202-84. Metronidazole (FS 42-0257-07). Sulfadimezin (GF-X, item 642). Propolis extract oil 15%, propolis TU GOST 28886-90. Potato starch (GOST 7699). The crystalline glucose (GOST 975). Purified water (FS 42-2619-97).

As a result of experimental studies it was found that gelatin capsules (ovule) consisting of gelatin, Dimethicone, glycerol, and purified water, have high bioavailability and a number of advantages: they have a beautiful appearance - smooth, oval-shaped capsules are 1.8 cm long and 1 cm in diameter; therapeutic effect of the content appears to control the beginning of the release of metronidazole and sulfadimezin of capsules was observed for 2-3 minutes, complete dissolution of the capsule shell is marked on the 10-11 minute and complete release of drugs released from the granules to the 30th minute. The gelatin shell, dimetikona, glycerol, and purified water impermeable to volatile liquids, gas, oxygen, air (which is very important for the safety of the easily oxidizable funds). Capsules (ovule) - soft, dosage form very promising for applications in gynecology. 15% oil extract of propolis contributes to a better distribution of the granules with metronidazole and sulfadimezin consisting �of cipient. Giving the drug form of capsules (egg-shaped vaginal suppositories) provides the convenience and hygiene of application, storage stability. Glucose, being a part of the drug, in combination with potato starch performs the function of the filler granules, and is also a nutrient substrate for Lactobacillus, the normal vaginal microflora. Lactobacilli break down glucose with the formation of lactic acid, providing the acidic environment of the vagina. Introduction in the drug of propolis extract in the amount of 15% combined with sulfadimezin and metronidazole increases antimicrobial activity, tissue regeneration, promotes the expression of anti-inflammatory, analgesic, hemostatic, immunomodulatory, reparative effect of the dosage form.

In addition to the existence of the known properties of each component of the claimed composition, in the aggregate, is increasing its exposure to that because, obviously, the effect of their synergies.

Example 1. Composition of 1 capsule (egg-shaped vaginal suppositories): sulfadimezin 0.05 g; metronidazole 0.01 g, potato starch 0.02 g, glucose 0.04 g, polyvinyl alcohol 5% 0.07 g, 15% oil propolis extract 1.0 g; gelatin 0.2 g; Dimethicone 0.04 g; glycerol, 0.4 g; purified water 0,37.

Calculated amount of active ingredients (metronidazole, sulfadimezin) are mixed and ground in a mortar with ASD�read a number of excipients (starch, glucose). The mixture is evenly moistened with the prepared solution of the film former PVA 5% (polyvinyl alcohol) and wipe through a sieve with 0.5 mm. d the resultant granulate is dried at a temperature of 50-60°C in a drying Cabinet. Then spend the fractional analysis, sifting the granules obtained through a system of sieves (Figure 1). After obtaining the desired fractions, the pellets are injected into a dispersion medium MEP 15%. The resulting suspension is homogenized, standardize. Preparing the composition for a capsule shell. In beaker pre-soaked gelatine in the calculated amount of water (60-90 minutes), melt in a water bath at a temperature not exceeding 70°C, add the Dimethicone and glycerin. To remove air without mixing incubated for 30 minutes at a temperature of 45°C, when poured into a porcelain crucible. Metal mold (olive) wiped with gauze soaked in liquid paraffin, cooled in a refrigerator at a temperature of 3-5°C for 5-6 minutes and immersed in a gelatinous mass at a temperature of 38-40°C for 1-2 seconds. Shape gently lift, rotating in a horizontal position about its axis, and placed in a refrigerator for 7-10 minutes, after which the capsules are carefully incised with a scalpel or razor blade at the base of the olive. Quality capsules judging by appearance, the withdrawal of the olive and the integrity of the shell. Further �apolnet mixture of excipient, containing granules sulfadimezin and metronidazole at 15% oil extract, and then the remaining gelatin mixture is filled capsules are sealed.

Received ovule correct form, the mass is easily removed with olive sheath elastic, soft, good filling eccipienti.

Example 2.

Composition of 1 capsule (egg-shaped vaginal suppositories): sulfadimezin 0.05 g; metronidazole 0.01 g, potato starch 0.06 g, polyvinyl alcohol 5% 0.07 g, 15% oil propolis extract 1.0 g; gelatin 0.2 g; Dimethicone 0.04 g; glycerol, 0.4 g; purified water 0,37.

Calculated amount of active ingredients (metronidazole, sulfadimezin) are mixed and ground in a mortar with the calculated amount of excipients starch. The mixture is evenly moistened with the prepared solution of the film former PVA 5% (polyvinyl alcohol) and wipe through a sieve with 0.5 mm. d the resultant granulate is dried at a temperature of 50-60°C in a drying Cabinet. Then spend the fractional analysis, sifting the granules obtained through a system of sieves. After obtaining the desired fractions, the pellets are injected into a dispersion medium MEP 15%. The resulting suspension is homogenized, standardize. Preparing the composition for a capsule shell. In beaker pre-soaked gelatine in the calculated amount of water (60-90 minutes), melt in a water bath at temperatures� not more than 70°C, add Dimethicone and glycerin. To remove air without mixing incubated for 30 minutes at a temperature of 45°C, when poured into a porcelain crucible. Metal mold (olive) wiped with gauze soaked in liquid paraffin, cooled in a refrigerator at a temperature of 3-5°C for 5-6 minutes and immersed in a gelatinous mass at a temperature of 38-40°C for 1-2 seconds. Shape gently lift, rotating in a horizontal position about its axis, and placed in a refrigerator for 7-10 minutes, after which the capsules are carefully incised with a scalpel or razor blade at the base of the olive. Quality capsules judging by appearance, the withdrawal of the olive and the integrity of the shell. In the future, with a mix of excipient containing granules sulfadimezin and metronidazole at 15% oil extract, and then the remaining gelatin mixture is filled capsules are sealed.

Received ovule correct form, the mass is easily removed with olive sheath elastic, soft, good filling eccipienti.

In the specified composition is free of glucose, but glucose is included in the drug composition is a nutritional substrate for Lactobacillus, the normal vaginal microflora. Lactobacilli break down glucose with the formation of lactic acid, providing the acidic environment of the vagina. Introduction of potato starch as a filler in the composition granule affect the acidic environment of the vagina.

Example 3. Composition of 1 capsule (egg-shaped vaginal suppositories): sulfadimezin 0.05 g; metronidazole 0.01 g, potato starch 0.02 g, glucose 0.04 g, polyvinyl alcohol 5% 0.07 g, 15% oil propolis extract 0.5 g; methylcellulose solution 3% 0.5 g; gelatin 0.2 g; Dimethicone 0.04 g; glycerol, 0.4 g; purified water 0,37.

Calculated amount of active ingredients (metronidazole, sulfadimezin) are mixed and ground in a mortar with the calculated amount of excipients (starch, glucose). The mixture is evenly moistened with the prepared solution of the film former PVA 5% (polyvinyl alcohol) and wipe through a sieve with 0.5 mm. d the resultant granulate is dried at a temperature of 50-60°C in a drying Cabinet. Then spend the fractional analysis, sifting the granules obtained through a system of sieves. After obtaining the desired fractions, the pellets are injected into a dispersion medium containing 3% aqueous solution of methylcellulose (MC) and MEP 15% (in the ratio 1:1). The resulting suspension is homogenized, standardize. Preparing the composition for a capsule shell. In beaker pre-soaked gelatine in the calculated amount of water (60-90 minutes), melt in a water bath at a temperature not exceeding 70°C, add the Dimethicone and glycerin. To remove air without mixing incubated for 30 minutes at a temperature of 45°C, when poured into a porcelain crucible. Meth�licencia forms (olive) wipe gauze swab moistened with paraffin oil, is cooled in the refrigerator at a temperature of 3-5°C for 5-6 minutes and immersed in a gelatinous mass at a temperature of 38-40°C for 1-2 seconds. Shape gently lift, rotating in a horizontal position about its axis, and placed in a refrigerator for 7-10 minutes, after which the capsules are carefully incised with a scalpel or razor blade at the base of the olive. Quality capsules judging by appearance, the withdrawal of the olive and the integrity of the shell. In the future, with a mix of excipient containing granules sulfadimezin and metronidazole in 15% of the oil extract of propolis and 3% solution of methylcellulose (1:1), and then the remaining gelatin mixture is filled capsules are sealed.

Received ovule correct form, the mass is easily removed with olive sheath elastic, soft, good filling eccipienti. After 1 day of storage the capsules (egg-shaped vaginal suppositories) is softened and observed breaks, capsules (ovule) not be stored, because as eccipienti the composition should not include a component - purified water contained in the solution of methyl cellulose 3%, which is part of accipient - dispersion medium.

The given examples show that the optimal from the point of view, ease of use, effectiveness of treatment is the composition described in example 1.

After conducting a full-scale clinical trials � of developing methods of quality control of capsules (egg-shaped vaginal suppositories) plan on obtaining monograph.

1. A tool for the integrated treatment of chronic post-abortion endometritis, pelvic inflammatory disease, made in the form of a capsule (egg-shaped vaginal suppositories) containing the active ingredient oil extract of propolis (WEP) 15%, as the shell of gelatin, glycerin and purified water, characterized in that it additionally contains as active ingredients sulfadimezin and metronidazole in the form of granules, as auxiliary substances dispersed phase comprising the suspended eccipienti, 5% polyvinyl alcohol (PVA), potato starch and glucose, and as the shell of the capsule Dimethicone, in the following ratio of components, g per 1 capsule:

Metronidazole0,01
Sulfadimezin0,05
Glucose0,04
Starch0,02
PVA 5%0,07
MEP 15%1,0
Gelatin0,2
Glycerin0,4
Dimethicone0,04
Purified water0,37

2. A compound according to claim 1, characterized in that as solvent oil extract of propolis contains vegetable oil.

3. A compound according to claim 1, characterized in that as solvent, the polyvinyl alcohol contains water purified.



 

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