Ointment "amulet for the treatment and prevention of infectious - inflammatory gynecological diseases and dysbacteriosis

 

(57) Abstract:

The invention relates to pharmaceutical industry and relates to drugs used in obstetric practice for the treatment and prevention of infectious and inflammatory diseases and dysbacteriosis. The ointment contains as the active biological component stabilized liquid culture of lactobacilli (107-1010CFU/ml) in an amount of 5-50 wt.%. Stabilization of the active biological component, ensuring the preservation of a therapeutic dose of viable lactobacilli, is achieved due to the transfer of liquid culture of lactobacilli in the gel state by adding a surfactant in the amount of 3-5 wt.% and ointment bases to 100%. The technical result is to extend the scope of application. 1 C.p. f-crystals, 2 tab.

The invention relates to pharmaceutical industry and relates to drugs used in obstetrics and gynecology for the treatment and prevention of infectious and inflammatory diseases and dysbacteriosis.

Famous liniment of syntomycin containing antibacterial substance (syntomycin) and ointment base used for the treatment of the AI (1). The syntomycin is an antibiotic of the group of chloramphenicol and causes many side effects (bone marrow suppression, dyspeptic symptoms, irritation of the mucous membranes of the mouth, skin rashes and other). Also liniment of syntomycin used to treat cracked nipples breast postpartum, although this drug causes goiter and toxic to the body of the newborn.

Known suppositories with Lactobacterin and allatom obtained on the basis of dry freeze-dried biomass (2). Suppositories are used to treat infectious and inflammatory gynecological diseases involving violation of microflora. The disadvantages of this dosage form are: the limited scope of application (cannot use in pediatric gynecology and prevention of mastitis), the drug's high cost associated with the use of dry biomass.

The closest analogue of the present invention are candles with lactic acid bacteria on the basis of liquid biomass of the strain Lactobacillus acidophilus CMPM IN-3324(3). The disadvantage of these candles is that used in the production unstabilized native liquid culture of lactobacilli and their life-cycle costs is nedostatkov designed ointment for the treatment and prevention of infectious-inflammatory gynecological diseases and dysbacteriosis, contains stabilized liquid culture of lactobacilli.

The invention consists in that ointment contains as the active biological component liquid culture of lactobacilli one or a mixture of strains used in the production of lactacidemia probiotics, and stabilization of liquid bacterial culture is achieved by its translation in the gel state by surface-active substances (surfactants). As the surfactant used sodium carboxymethylcellulose, a gel of aluminum hydroxide and other substances that provide a stable gel. Such diffusion-osmotic changes in the properties of the liquid phase of the culture significantly slows down the metabolic processes of cells and, consequently, the process of their death. The use of the gel allows obtaining ointment with a long shelf life.

The use of stabilized liquid bacterial culture for production of ointment eliminates the stage of drying the bacterial component, associated loss of viable cells and the extra expense of biomass, to shorten the production cycle, which leads to reduction in the cost of the drug. Stability bacteriologist in suppositories on the basis of dry biomass and significantly exceeds the stability of the bacterial component closest analogue - candles based on liquid biomass of the strain Lactobacillus acidophilus CMPM IN-3324 (PL.1).

The technical result consists in the development of highly efficient, stable and easy to manufacture dosage forms containing lactobacilli, which have broad application in the prevention and treatment of infectious-inflammatory gynecological diseases and dysbacteriosis.

For the preparation of ointments can be used for the culture of lactobacilli following industrial strains: L. plantarum 8P-A3, L. fermentum 90-TC-4, L. acidophilus TO3W24NK1, 100 AL, etc. used in the production of lactacidemia probiotics. Preparation of a bacterial component includes obtaining suspension of lactobacilli containing 107- 1010CFU/ml the number of viable cells is ensured by the cultivation of industrial strains on a regulated nutrient media. The liquid bacterial culture was transferred to a gel-like state.

Experimentally determined the optimal content of liquid culture of lactobacilli (wt.%) in the grease - 5-50. The quantity of liquid culture of lactobacilli less than 5% does not provide a uniform distribution of cells in the ointment culture of lactobacilli more than 50% cannot provide a homogeneous emulsion system, the stability of the dosage form during storage and leads to excessive bacterial component.

As ointment bases are permitted for medical use hydrophobic and debilnye basics with the addition of emulsifier (distilled monoglycerides and others). In table.2 shows examples of formulations ointment.

The process of manufacturing the ointment is carried out in aseptic conditions. Ointment bases before cooking is subjected to sterilization. The temperature of the ointment bases when introducing a bacterial component should not exceed (421)oTo prevent cell death. Get the ointment contains 107- 1010CFU/g

Example preparation of ointments

To a suspension of lactobacilli containing 107- 1010CFU/ml (obtained after cultivation of one or a mixture of industrial strains) add synthetic or natural surfactants to obtain a stable gel. To the melted wax basis, cooled to 421oTo add a bacterial component in the form of a gel and mixed until a homogeneous ointment.

The ointment contains the following ratio of components, wt.%:

Liquid culture of lactobacilli (107- 1010CFU/ml-WA, 25 years old, came to the antenatal clinic with complaints of excessive discharge from the genital tract with an unpleasant odor, irritation of the external genitalia in the form of itching and burning. Microscopic examination of vaginal smears stained by gram stain revealed: the abundance of coccal flora, the absence of lactobacilli, "key cells". Fungi, Trichomonas, gonorrhea is not detected. Diagnosed with bacterial vaginosis. Treatment cream with 2% clindamycin as vaginal swabs 2 times a day for 7 days. Prevention of relapse and to normalize the microflora of the vagina assigned to offer ointment. The ointment was applied intrawaginalno on the tampon 1 time a day for 10 days. At the end of the treatment the patient did not show any subjective complaints, in a smear from a vagina was attended by lactobacilli.

Example 2. To the children's gynecologist turned M-VA with a girl 5 years. The girl was worried about itching and burning in the vulva. During examination: mucous discharge from the genital tract, redness of the vulva. Microscopic examination of secretions revealed: neutrophils 5-10 in sight, plenty of coccal flora, lactobacilli are absent. Mushrooms, gonorrhea, Trichomonas is acene treatment: toilet vulva 2-3 times a day decoction of chamomile, calendula; the application of the proposed ointment 1 time a day at night. After ten days of treatment, the girl had no complaints.

Example 3. In female consultation has addressed Peninsula, 63 years, with complaints of itching of the vagina, pain during coitus. Gynecological examination revealed: the mucosa of the vulva and vagina is smooth, shiny, pale pink mucous discharge, scanty. When corporateregister.com examination of vaginal smears detected atrophic cells. Diagnosed with atrophic vulvovaginitis. Assigned to hormone replacement therapy and the proposed ointment for treatment of external genital organs and intervaginal on the tampon 1 time a day for 10 days. After a course of therapy ointment patient noted a significant decrease in clinical symptoms. Recommended in combination with hormone replacement therapy periodically treatments ointment tampons.

The proposed dosage form ointment containing Lactobacillus, easy to use and has a wide scope in obstetric practice: the treatment of infectious-inflammatory diseases and vaginal dysbiosis, atrophic colpitis, especificas is established and postoperative infectious complications in gynecological patients. Ointment applied intrawaginalno on the swab for treatment of external genital organs and for drawing on the nipple and areola mothers. In the treatment of cracked nipples breast puerperas ointment relieves pain, promotes rapid healing of fractures, eliminates infection of the skin breast pathogenic flora, prevents the feeding of infants and contributes to the formation of normal bacteriocins newborns.

Sources of information

1. Mashkovsky M. D. Medicines. 4.2. - M.: Medicine, 1993. - S. 303-304

2. Sharipova I. S., Sergounin Century. And., Krasinski, E. L. et al. Evaluation of treatment-and-prophylactic actions candles with Lactobacterin on the microbiocenosis of intestines of children. IMEI.- 6. - 1993. - S. 30-31.

3. Patent SU 1491884 A1 "bacterial Strain Lactobacillus acidophilus TO3W24used for cooking bakpreparatov to normalize the microflora in the human microflora of the vagina".

1. Ointment for the treatment and prevention of infectious-inflammatory gynecological diseases and dysbacteriosis, containing the active biological component and ointment base, characterized in that as the active biological component it contains liquid wt. %:

Liquid culture of lactobacilli (107-1010CFU/ml) - 5-50

SURFACTANT - 3-5

Ointment base - Rest

2. Ointment under item 1, characterized in that it contains Lactobacillus one or a mixture of strains used in the production of lactacidemia probiotics, in the amount of 107-1010CFU/g

 

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