Tampon coating with fatty acid esters and effectiveness of toxin inhibition

FIELD: medicine.

SUBSTANCE: invention refers to medicine. What is described is using active ingredients as exemplified by GML (Glycerol Monolaurate) on a fibrous absorbent structure, such as viscose fibre, used for tampons production, in the very low concentrations enables maintaining effectiveness on the inhibition of synthesis of a toxic shock syndrome toxin 1 (TSST-1) produced by S.aureus, without evident microorganism elimination for the purpose of achieving the desired reduction of the toxin concentration and avoiding undesired impurities.

EFFECT: achieving the desired reduction of the toxin concentration and avoiding undesired impurities.

16 cl, 6 tbl, 3 ex

 

The invention relates to concurrently filed patent applications, owned by one patientsafety, under the heading "composition of the coatings and the substrates with the coating for the production of articles intended for use in contact with surfaces of the body", serial No. U.S. 61/116785 (document a patent attorney No. PPC-5323USPSP), filed on November 21, 2008, and serial No. U.S. 61/116826 (document a patent attorney No. PPC 5322USPSP) under the heading "cooling Chamber", filed November 21, 2008.

Background of invention

The invention relates to absorbent products, including tampons, sanitary napkins, wound dressings, etc. designed to absorb secretions, such as menstrual periods, blood and Raney exudate. The present invention includes determining the preferred methods of placing esters of fatty acids, such as glycerol monolaurate (GDF) on the surface of the product and(or) on the surface of 10% of the fibres used for manufacturing products that help reduce the formation of toxins, microorganisms, when using the significantly lower concentrations of additives in comparison with described in U.S. patent No. 5641503.

Adding GDF directly into the fibers leads to an undesirable increase of extractables solvent SOS is avow and foaming.

In previously published sources, including U.S. patent No. 57532522, 5679369, 5705182, 5641503 and 5389374, reported the potential use of surfactant - GDF - as coatings for fiber tampons. All patents describe the addition of GDF to tampons to reduce the synthesis of toxins by the bacteria Staphylococcus aureus (S.aureus), as well as other bacteria, including Strept. spp. The uniqueness of the GDF as an additive for use in tampons is that the solubility of GDF in water is significantly less than 10%, therefore, the substance remains on the material of the tampon, providing long-lasting effect. Thus, GDF better retained on the fibers in comparison with other known coatings for fibers that are water-soluble, and, therefore, in any preferred embodiment, the placement of standard coatings for fibers on the swab will be immediate leaching of such coverage due to the complete solubility of the surfactant coating. In addition, the fact that GDF can reduce the synthesis of TSST-1 without significant effect on the viability of S.aureus, allows us to conclude that the addition of GDF to tampons does not violate the normal flora of the vaginal fornix.

In these patents describes the use of a GDF on the fibers and / or coatings tampons in number at m the re of 0.1%. In the patents described a simple application of the additive on the surface of the tampon pipette, without a description of the potential benefits of uniformity, the ability to minimize the use of additives and accommodation options GDF on the swab to ensure the GDF impact on the synthesis of toxins S.aureus at low extraparameter and reduced foaming. In these patents also do not describe how to add a GDF in an effective concentration in the structure of the absorbent material (inside or on the surface) to ensure consistent and appropriate level of efficiency while maintaining the GDF impact on the synthesis of toxins by bacteria.

Adding GDF only on the surface and(or) only 10% of the fibers leads to a substantial decrease of the synthesis of TSST-1 bacteria S.aureus. TSST-1 is the toxin responsible for the occurrence of toxic shock, which represents a severe condition associated with the use of tampons.

Brief description of the invention

The invention relates to inhibition of the synthesis of the toxin that causes toxic shock, TSST-1, synthesized by bacteria S.aureus, without destroying microorganisms, to ensure the desired reduction of the concentration of the toxin so that the tampon was not introduced in excess, ethers and water-soluble substances, and that is not about aciravati excessive foaming. To achieve these goals as an active ingredient for testing was selected GDF. At concentrations described in the sources in accordance with the prior art, GDF provides a reduced concentration of TSST-1, however, the swabs are characterized by a high level of extraction agents, and their use is accompanied by foaming, which may be undesirable. Thus, one aspect of the present invention is that when applying GDF only part of the fiber (for example, 10%)used for the manufacture of tampons, allows to obtain the structure of absorbent material with acceptable level of extraction and foaming while maintaining the level of reduction in TSST-1 without a significant impact on the viability of S.aureus. Another aspect of the invention is preferred accommodation GDF plastic and(or) non-woven surface of the tampon, and not on the fibers, which also leads to a significant reduction in the concentration of TSST-1 without affecting the concentration of S.aureus.

A detailed description of the preferred embodiments

The invention describes the application of active ingredients, an example of which is the GDF, absorbent fibers, such as viscose fiber, used in the manufacture of tampons. It is known that the addition of GDF helps inhibi the SQL synthesis of the toxin, which is the cause of toxic shock, TSST-1, secreted by S.aureus, without destroying microorganisms, in order to achieve the desired reduction in the concentration of toxin. However, when you try to bring tampons with the addition of GDF on the market in some countries have any questions related to testing the level of cleanliness. GDF and similar active ingredients possess surface-active properties. Thus, they can increase the level of extraction and foaming. This may cause these useful compositions will be considered "impurities". Indeed, at the concentrations described in the sources of prior art tampons containing GDF, are characterized by this level of extraction and / or foaming, which exceeds the statutory individual competent authorities.

Therefore, application of GDF only a part of the fibers (for example, 10% fiber by weight)used for the manufacture of a tampon, allows to maintain the level of extraction and foaming within acceptable limits, and to ensure sufficient reduction of the synthesis of TSST-1 without a significant impact on the viability of S.aureus. Alternatively, application of a GDF on plastic and/or non-woven coating a tampon instead of applying it on the fiber also helps to achieve substantial snizeni the concentration of TSST-1 without affecting the concentration of S.aureus. In addition, the authors found that the combination of these approaches allows you to create a tampon with the lowest level of the active component, which can be considered as an impurity, but the level of active component will be sufficient to substantially inhibit the ability of S.aureus to synthesize TSST-1. Such approaches can create a swab containing absorptive fibers are quite small amounts of GDF - approximately 0.02% of the weight. or less able to inhibit the synthesis of TSST-1 and meet the desired levels of "impurities" when testing on foaming, the content of ester-soluble and water-soluble substances.

The authors found that providing effective reduction in the concentration of toxin in the number of esters of fatty acids can be added to the swab in a unique way, providing low foaming, the content of ester-soluble and water-soluble substances (as described below). The authors found that the content of esters of fatty acids on the fibrous absorbent structure is less than 0.1 wt%, preferably less than 0.08%, more preferably less than 0.05 wt%, even more preferably less than 0.03 wt%, most preferably less than 0.02 wt%. can afford to create an absorbing material is able to pass tests on the foam, as it contains less than the 0.3% of the ester-soluble substances according to the test on the content of the ester-soluble substances and less than 0.7% of water-soluble substances according to the test on the content of water-soluble substances.

The authors found that the monitoring of the application of very low concentrations of GDF on the fibers is difficult. Thus, the authors have found that you can control the application of high concentrations of GDF on the fiber and then blend fibers treated with GDF, with other fibers to obtain low concentrations of additives, preferred in the present invention.

The authors found that the coating of the active ingredient, such as GDF, branched fiber provides effective inhibition of the synthesis of TSST-1 with a low level of extraction and foaming. Not wanting to be limited by this theory, the authors suggested that the additional surface area arising from the use of branched fibers, in comparison with a predominantly cylindrical standard viscose fibers represents an additional area for the application of GDF, providing a significant inhibition of TSST-1 even at a lower total concentration of GDF than described in accordance with the previous prior art. This allows to achieve effective inhibition of the synthesis of the toxin without increasing extraction and foaming to an undesirable level. Thus, tampons treated with GDF provide effective inhibition of the synthesis of the toxin and meet the established standard is there purity. Described a significant improvement allows you to create a healthier tampons without compromising purity and safety of the product.

Also, the authors found that the coating containing approximately 5 wt%. the active ingredient, more preferably from about 0.5 to about 4 wt%. the active ingredient, most preferably from about 1 to about 3 wt%. the active ingredient, alone or in combination with processed active ingredient fibrous structure of the absorbent material provides the ability to effectively reduce the production of toxin in the product. This can be done as described in patent applications serial No. U.S. 61/116785 (document a patent attorney No. PPC 5323) under the heading "composition of the coatings and the substrates with the coating for the production of articles intended for use in contact with surfaces of the body" and serial No. U.S. 61/116826 (document a patent attorney No. PPC 5322) under the heading "cooling Chamber", filed November 21, 2008, the contents of which are incorporated herein by reference.

The active ingredient may be applied to the material by standard methods, applicable for liquids with low viscosity, such as spraying, application with a roller, causing the contact the way (by touch) and application through the slot. The preferred methods are the application of contact and application through the slot, due to the simplicity and uniformity of application.

The authors found that the active ingredient, for example, GDF, can be dissolved in the diluent at a temperature below the melting temperature, component 58-60°C. Preferred is heated up to 60°C or higher to ensure the stability of the composition and a low viscosity. For coating the contact, the amount of additive and the uniformity of deposition is controlled by the speed of the roller and the speed of the feed line. When applying through the slot number of the additive is determined by the size of the slot, the speed of the pump and the speed of the feed line.

GDF is well combined with the diluents. In fact, the addition of GDF can make the composition even more stability in comparison with the dilution medium without GDF. The temperature of solidification depends on the % content of GDF, and often the crystallization temperature of the finished formulation is slightly higher than room temperature. Preferred is a liquid composition in the coating process for a simpler configuration of the equipment and subsequent transfer to the solid state after application to keep p the closure on film and nonwoven surfaces. Achieving such a result is associated with certain difficulties when using formulations with a high content of GDF. However, we found that a composition containing 50% GDF/35% BCP/15% SPAN® 80, characterized preferred position zone of the phase transition. We also found that the time of penetration of water through the coating is very low even at high content of hydrophobic GDF. Water penetrates faster than through film coating with hydrophilic PEG, BCPs and TWEEN® 20.

When using such coating compounds, we found that the composition based on the GDF can be evenly distributed on one side (the side of the coating) of the perforated film material in the form of small deposits, such as droplets. On a non-woven coating composition based on GDF can be distributed relatively evenly. Microscopic examination revealed that a large part of the composition is located in the small pores around areas termodonte. Thus, the most preferred matrix for the coating is a non-woven material. This allows non-woven material the best way to capture and retain the coating composition during binding of coverage with a low content of the composition on the basis of GDF with the fibers to achieve the highest stability of the coating swab.

Below is the detailed description of the invention examples, related to hygienic tampon comprising an absorbent material and is permeable to liquid coating material with the addition of glycerol monolaurate and glycerol of dilaurate showing efficacy in inhibition of the synthesis of the toxin toxic shock-1 bacteria S.aureus in the presence of the bacteria in contact with the swab. From the description it becomes clear that the principles on which is based the present invention are applicable to other absorbent products, such as wound dressings, disposable diapers, sanitary napkins and other types of swabs designed for medical, surgical, dental or nasal use.

A COMMON METHOD of MAKING TAMPONS THAT are the SUBJECT of the PRESENT INVENTION

The mixture of glycerol monolaurate, glycerin of dilaurate and very low concentrations of glycerol dilaurate, commercially available under the name Monomuls 90 L-12, was acquired by the company Cognis Corporation, Ambler, Pennsylvania, USA. This mixture, designated herein by the acronym GDF, was subjected to analysis, which showed that the mixture contains >90% weight. glycerin of monolaurate, while the glycerol dilaurate and glycerol dilaurate make up the remaining 10%. It is known that the GDF has limited antimicrobial properties, detoxi the Yong for a person.

Fiber GALAXY™ (viscose fibers, trilobal, supplier - Kelheim GmbH) were subjected to treatment with the compound containing 0.2 wt%. GDF, using the following method:

- prepared in situ solution of sodium laurate concentration equivalent to 0.2 wt%. solution GDF, by adding sodium hydroxide and lauric acid and heating to a temperature of ~80°C for approximately 30 minutes;

- added GDF to obtain 5% of the original mortar;

- added the original solution in the cuvette for preparation of a composition intended for the coating of viscose fibers at a speed that allows you to reach the target content GDF in the floor; pH content of the cell should be maintained at a level of approximately 4;

- sprayed coating on the layer of staple fibers of viscose and the material of the Galaxy;

- missed a layer of fibers through pressure rollers to add approximately 100% moisture;

- dried fibers in thermostat.

Then the obtained fiber was mixed with the raw standard viscose fibers in the ratios shown in table 1, and mixed fibers formed tampons in accordance with the General principles contained in the following sources: Friese et al., U.S. patent No. 6310269, Leutwyler et al., U.S. patent No. 5832576; PPC708, patent application US from Schoelling No. 2002/0151859 the use of a perforated film coating described in U.S. patent No. 6537414; the contents are incorporated herein by reference.

The coating was removed, after which the fibrous absorbent structure was subjected to tests to determine the levels of foaming, the content of ester-soluble and water-soluble substances.

TESTING METHODS

Test level foam

15.0 g pad fibers were placed in a suitable vessel, was added 150 ml of water (deionized), closed vessel and left for soaking for 2 hours. Poured the solution was carefully pressed the remaining liquid from the sample with a glass rod and stirred. Take 10 ml of the solution was placed in a glass graduated cylinder 25 ml with glass stopper, an outer cylinder diameter of 20 mm, wall thickness is not more than 1.5 mm, the Cylinder was previously three times opalenet sulfuric acid and water (deionized). The cylinder was vigorously shaken 30 times within ten seconds left for one minute and repeat the shaking. Five minutes later checked the foaming. The test result was indicated as "satisfactory"if the foam covers the entire surface of the liquid, or "unsatisfactory"if the foam covers the entire surface of the liquid.

Test the content of ester-soluble substances

5,00 g fiber pad was placed in the extraction apparatus and the ex who was regionali the ether with a velocity of at least four extraction per hour for four hours. Evaporated the ether extract was dried residue to constant weight at a temperature of from 100 to 105°C.

Test the content of water-soluble substances

5,00 g pad fibers were boiled in 500 ml of water (deionized) for 30 minutes with frequent stirring. To compensate for water loss due to evaporation. Poured the liquid was carefully pressed the remaining liquid from the sample with a glass rod and stirred. Filtered hot liquid. Evaporated 400 ml of the filtrate (equivalent to 4/5 weight of sample taken), and dried residue to constant weight at a temperature of from 100 to 105°C.

The way of the tampon in the bag"

This test method has been described in the publication Reiser et al., Journal of Clinical Microbiology, Vol.25, August 1987, pp.1450-1452, method, incorporated herein by reference. Method tampon in the bag" was used in accordance with the description presented in the publication Reiser et al. in 1987, but with regard to S.aureus strain Mn8, synthesizing TSST-1, obtained from Dr. Patrick Liberta from the University of Minnesota, Minneapolis, Minnesota, to assess the impact of GDF on the synthesis of the toxin. Seed material was prepared by transfer of S.aureus strain Mn8 in a nutrient medium and incubating the culture for 18-24 hours at 37°C before use.

In each of the ten cultural promero is of 3.8×20 cm was placed 100 ml of cardio-cerebral agar (BHI) (acquired in the company Difco Laboratories, , Detroit, Michigan, USA). Have been manufactured and sterilized cellulose bags in accordance with the description Reiser et al. Sterile cellulose bags were planted above the suspension S.aureus in quantities sufficient to achieve by the beginning of the test concentration of 1×107CFU/ml of bacteria S.aureus.

Before starting the test from the swabs was cut free portion of the cord. Each test pad treated with GDF (samples A, B and C), were placed in sterile cellulose bag containing bacteria S.aureus and then each bag was introduced into a culture tube containing BHI. Laid three control sample, among which was one tampon without GDF for comparison with the test tampons, to determine the reduced synthesis of the toxin.

The table below shows data on the concentration of toxin toxic shock-1 determined using enzyme-linked immunosorbent assay (ELISA) after incubation S.aureus for 24 hours at 37°C.

EXAMPLES

Example 1

To determine the possibility of adding to the absorbent material effective in reducing the concentration of the toxin amount of GDF at low concentrations of ester - and water-soluble substances and the foam coating on the basis of the GDF was applied to viscose fibers Galaxy™ for content GDF 0.2 percent, after which viskazivalsya Galaxy™ with a coating of GDF were mixed with a standard viscose fibers without processing GDF in the ratios listed in table 1. The resulting mixture of fibers by compression tampons were manufactured with a perforated film coating (coating without GDF).

Table 1
SampleThe mixture Galaxy/GDFA mix of Plain viscoseGDF on the absorbent material (wt%)Foaming Satisfactory/unsatisfactoryWater soluble matter (%)Ester-soluble matter (%)The average value of S.aureus Just SOMEJust TSST-1, mcgRed eye reduction. %
Control sample75% (without GDF)25%0Satisfactory6,9×10e10269--
A75% (0.2% weight. GDF)25%0,15Poor0,3 0,157,0×10e94,898%
D50% (0.2% weight. GDF)50%0,01Poor0,770,111,20×10e10<0,599%
C10% (0.2% weight. GDF)90%0,02Satisfactory0,470,072,9×10e10997%

In conclusion, it was found that the sample C was the only sample for which the effective concentration of GDF 0,02% of the mixture of fibers was achieved low foaming, low content of water-soluble and ester-soluble substances, as well as a significant decrease of the synthesis of TSST-1. Describes the mixture of fibers comprises 10% cellulose fiber content GDF 0.2% weight. and 90% of the fiber without coating GDF. Thus, the total concentration of GDF in the tampon is 0.02%, that is 5 times less than the content of GDF described patento U.S. No. 57532522, 5679369, 5705182, 5641503 and 5389374.

Example 2

Because the preferred concentration of GDF in the fiber is 0.02%, a study was conducted aimed at determining whether GDF only to be placed on the floor of the tampon in a sufficient concentration to achieve the same efficiency as when adding a GDF to the fiber. Adding GDF was considered for plastic and neoplastigenic coatings. The following describes the process of applying GDF on the nonwoven and film coating tampons:

Compositions for application:

GDF in a mixture of carrier composition 50% PG (propylene glycol or 1,2-propandiol)/50% SPAN® 80 (monooleate sorbitol from Uniqema) or a composition of 50% PEG (polyethylene glycol)/50% SPAN® 80.

The content of the GDF in the composition for application can be 1-80%, depending on the target concentration of GDF.

Tampons were made by applying a GDF on the floor (as perforated film coating, and non-woven floor) tampons and(or) by adding to the mixture of fibres to determine the concentration to achieve effective reduction of the level of toxins at low concentrations of ester - and water-soluble substances and low foaming. In this experiment, the swabs were subjected to S.aureus in a dialysis bag immersed in culture medium for 24 hours at 37°C. After incubation, the swabs were analyzed in order to determine the possible concentration of S.aureus and TSST-1 in accordance with the description, refer to the publication Reiser et al., Journal of Clinical Microbiology, Vol.25, August 1987, pp.1450-1452.

The base film was a three-layer film obtained by co-extrusion and consisting of polypropylene, polyethylene (PEEP, LDPE, HDPE) and titanium dioxide as a bleaching agent. The base film can also be produced by co-extrusion in the double-wall option scheme ABCBA, where A and B denote the same layers mainly made of polyethylene, and C - layer of polypropylene. After fabrication of the base film was unwrapped and performable using vacuum/hot air, then it was applied coating (50/50 PEG/SPAN) in the surface coating (Kiss Coating).

Damage included GDF in concentration, ensuring that GDF in the finished coating is from about 0.1 to about 5 wt%. Preferred levels of GDF in the finished coating ranged from approximately 1 to approximately 3 wt%. The coating was subjected to cooling to ensure the adhesion to the film. After that, the film is rolled and cut into pieces of required width for the manufacture of tampons.

Table 2
Effect of GDF deposited on performanance floor, on the synthesis of TSST-1 bacteria S.aureus
Sample DescriptionThe content of GDF coverage (% weight. swab)The content of the GDF in the fiber (% weight. swab)S.aureus All, CFU×108TSST-1 total, ugRestoration of TSST-1,%
The control pad00470207-
Swab test 100,02%3103086%
Swab test 20,08%03555275%
Swab test 30,15%0 1701,699%
Swab test 40,08%0,02%240<0,5>99%
Swab test 50,15%0,02%26<0,5>99%
Table 3
Effect of GDF printed on non-woven covering on the synthesis of TSST-1 bacteria S.aureus
Sample DescriptionThe content of GDF coverage (% weight. swab)The content of the GDF in the fiber (% weight. swab)S.aureus All, CFU×108TSST-1 µg totalRestoration of TSST-1%
The control pad00 15030-
Swab test 100,02%15970%
Swab test 2 floor 9 g/cm0,05%05,8<0,5>99%
Swab test 3 floor 9 g/cm0,05%0,02%5,0<0,5>99%

The data are shown in tables 2 and 3 show that the decrease in the concentration of the toxin can be achieved when the content of GDF less than 0.1%, specified in U.S. patent No. 5641503. In addition, the data allow us to conclude that the decrease in the level of toxin adding GDF to the fiber can be achieved when adding a GDF to the floor.

Example 3

Conducted a series of experiments aimed at determining whether an Addendum is their GDF to different types of fibers on the ability of GDF to reduce the concentration of TSST-1 without a significant impact on the viability of S.aureus. In addition, the requirements included the ability of the fibers to undergo foaming.

Were made tampons, in which the absorbent material used viscose fibers, using the following procedure:

Viscose staple fiber length (acquired in the company Kelheim GmbH, Kelheim, Germany) were processed by various structures. These compounds were designed to make the fiber wettability and ease of handling in the production process. Standard viscose fibers were treated with a composition based on ethoxylated stearic acid. The treated GDF fiber was caused to the structure based on the GDF for content GDF in the fibers of 0.1% weight. The treated fibers were dried and prepared for mixing, as described below.

Fiber GALAXY™ (viscose fibers, trilobal, supplier - Kelheim GmbH) were also subjected to treatment with different mixtures. Standard fiber GALAXY™ were processed complex monoufia palmitic/stearic acid and polyethylene glycol. Fiber GALAXY™ with the addition of GDF were treated with composition-based GDF for content GDF in the fibers of 0.1% weight. The treated fibers were dried and prepared for mixing, as described below.

Using carding equipment b is obtained a mixture of different processed GDF and standard fibers. Combed fiber networks were rolled into the fibrous cylinders. Fibers were mixed by hand and weighed to obtain the corresponding fibrous mixes, made in perforated plastic film (not processed GDF, unless otherwise stated)were subjected to thermoclean and was placed in the applicator for testing.

Swabs were subjected to testing in the Microbiology laboratory. The swabs were put into sterile dialysis tubes and seeded by S.aureus strain Mn8 at a concentration of 1.2×108CFU/ml. the Entire structure was immersed in a nutrient agar and placed in the incubator. After 18 hours incubation at 37°C dialysis tube was removed, and tampons to determine the level of TSST-1, and the total number of viable bacteria S.aureus in a tampon. The level of TSST-1 were determined by enzyme-linked immunosorbent assay (ELISA), and the total number of viable bacteria S. aureus was determined by a standard method such as pan-counting in accordance with the description Reiser et al, Journal of Clinical Microbiology, Vol.25, August 1987, pp.1450-1452.

Table 4
The influence of the viscose-treated GDF, and untreated fibers Galaxy on the synthesis of TSST-1
Description of the sample Treated viscose/raw fiber is Galaxy The content of the GDF in the fiber (% weight. swab)S.aureus All, CFU×1010Just TSST-1, mcg% reductionTest foaming Satis./neud
0/1000,0%2,4115-Satis.
2,6137
2,6118
2,798
2,7108
Mean = 2,6Average = 122
10/900,01%2,51212Satis.
2,5109
2,682
2,6145
2,6137
Mean = 2,6Average = 119
25/750,025%2,61170Satis.
2,5146
2,699
2,5132
2,6117
Mean = 2,6Average = 122
50/500,05%2,07350Satis.
2,169
2,382
2,146
2,037
Average = 2,1Average = 61
75/250,075%2,046 55Satis.
1,953
2,162
2,048
1,966
Mean = 2,0Average = 55

90/100,09%2,01591Bad.
1,913
2,011
2,19
2,19
Mean = 2,0Average = 11
100/00,1%2,11088Bad.
2,014
2,12,113
2,118
Average = 2,1Average = 14

The data in table 4 show that 0.1% of the content of the GDF in a tampon, consisting only of standard viscose fibers, reduces the synthesis of TSST-1 by 88%, however, this sample does not meet the requirements of the tests for foaming. Reducing the amount of the GDF to 0.075% reduces foaming, which allows the product to pass the test on the foam, but it is less effectively inhibits the synthesis of TSST-1.

Table 5
The influence of fibers Galaxy processed GDF, and untreated fibers Galaxy on the synthesis of TSST-1
Description of sample of the Raw fiber Galaxy/Galaxy GDFThe content of the GDF in the fiber (% weight. swab)S.aureus All, CFU×1010Just TSST-1, mcg% reductionTest foaming Satis./neud
100% no processing 02,4151Satis.
2,6137
2,6118
2,798
2,7108
Mean = 2,6Average = 122

90/100,012,14755%Satis.
2,161
2,049
2,153
2,160
Average = 2,1Average = 54
75/250,025%2,07350%Satis.
2,169
2,382
2,146
2,037
Average = 2,1Average = 61
50/500,05%2,14472%Satis.
2,239
2,026
2,131
2,032
Average = 2,1Average = 34

In contrast to the data presented in table 4, the data of table 5 demonstrate that the processing of the fibers Galaxy™ using GDF (0.1% weight. the treated fibers) allows to increase efficiency when mixed with untreated fibers Galaxy™. When the content of GDF 0.05% weight. in a mixture of fibers of the swab tested for foaming and reduces the synthesis of TSST-1 by 72%, without affecting the number of viable cells of S.aureus. The data in the table is e 5, show that the lowest of the concentrations of GDF (0,01%) allows to achieve a measured nominal decrease of the synthesis of TSST-1 by 55% in the absence of a significant effect on the concentration of viable bacteria S.aureus. Mixture-based fibers Galaxy processed GDF, are tested on foaming at all tested concentrations of GDF. This allows us to conclude that the increase in surface area of viscose fibers, trilobal provided by the use of fibers Galaxy™, allows the use of reduced concentrations of GDF preserving inhibitory effect against TSST-1 even at such low concentrations as 0.1 wt%. fibers used.

Table 6
The impact of untreated viscose fibres and processed GDF fibers Galaxy on the synthesis of TSST-1
Description of sample of the Raw standard viscose/Galaxy GDFThe content of the GDF in the fiber (% weight. swab)S.aureus All, CFU×1010Just TSST-1, mcg% reductionTest foaming Satis./neud
10% of untreated viscose 01,9185Satis.
2,0120
2,2135
2,1106
2,0147
Average = 2,1Average = 139
90/100,012,32180%Satis.
2,429
2,331
2,435
2,418
Average = 2,3Average = 27
75/250,025%2,04951%Satis.
2,1 57
2,282
2,079
2,071
Average = 2,1Average = 68
50/500,05%2,04457%Satis.
2,177
2,249
2,162
2,066
Average = 2,1Average = 60

The data in table 6 correspond to the case of mixing standard viscose fibers with fiber Galaxy™, treated with 0.1% GDF, to determine the effect of fibers Galaxy™ content GDF 0,1%, used in a mixture with the raw standard viscose fibers. Assessment made swabs showed that, as in the previous case, when using fibers Galaxy™treated GDF, tampons containing GDF in low concentrations, from 0.01% to 0.05%, reduce the synthesis of TSST1 on 51-80% in the absence of a negative impact on the population of viable cells of S.aureus. In addition, such mixtures of fibers are tested for foaming with all examined concentrations. The data in tables 5 and 6 demonstrate that the processing of the fibers Galaxy™ trilobal using GDF can be used to lower the concentration of GDF, making tampons can undergo foaming. In addition, these swabs provide a lower level of synthesis of TSST-1.

The above description, embodiments of the invention and examples are presented to provide a full and unlimited understanding of the entity described in the present patent of invention. Due to the fact that there are various modifications and embodiments of the invention, does not distort its essence and not beyond its scope, the invention is reflected in the claims below.

1. Absorbent product intended for the absorption of secretions, such as menstrual periods, blood and Raney exudate containing:
a) a fibrous absorbent structure;
b) coating essentially containing fibrous absorbent structure; and
c) an active ingredient selected from the group consisting of:
i) complex monoamino polyhydric aliphatic alcohols and fatty acids containing from eight to eighteen carbon atoms, with the specified complex monoether has come about at least one hydroxyl group, associated with the residue of aliphatic alcohol;
ii) complex diesters of a polyhydric aliphatic alcohol and a fatty acid containing from eight to eighteen carbon atoms, with the specified complex fluids has at least one hydroxyl group associated with the residue of aliphatic alcohol; and
iii) mixtures of these complex monoamino and diesters; and
where fibrous absorbent structure:
A) contains the active ingredient in an amount up to about 0.05 wt%.;
B) contains less than 0.3% ester-soluble substances in accordance with the test content of the ester-soluble substances;
C) contains less than 0.7% of water-soluble substances in accordance with the test content of water-soluble substances;
D) tested on pricing; and
and where the coating is deposited the active ingredient in an amount up to 5% weight.,
and where the amount of active ingredient to be placed on the surface of the fibrous absorbent structure of the fiber and the coating is sufficient for inhibition of the synthesis of the toxin toxic shock-1 bacteria Staphylococcus aureus, when said product is exposed to these bacteria.

2. Absorbent product according to claim 1, in which the fibrous absorbent structure includes a branched fiber.

3. Absorbent product according to claim 2, in which the branched hair is on covered active ingredient.

4. Absorbent product according to claim 3, in which the fibrous absorbent structure contains less than about 75 wt%. covered active ingredient branched fibers.

5. Absorbent product according to claim 1, in which the active ingredient is present in amounts of less than about 0.02% weight. fibrous absorbent structure.

6. Absorbent product intended for the absorption of secretions, such as menstrual periods, blood and Raney exudate containing:
a) a fibrous absorbent structure having branched fibers;
b) a sufficient amount of active ingredient deposited on the fibers with absorbent structure and effective in inhibition of the synthesis of the toxin toxic shock-1 bacteria Staphylococcus aureus, if the specified product is exposed to these bacteria;
c) a coating containing fibrous absorbent structure
where the active ingredient is chosen from the group consisting of:
i) complex monoamino polyhydric aliphatic alcohols and fatty acids containing from eight to eighteen carbon atoms, with the specified complex monoether has at least one hydroxyl group associated with the residue of aliphatic alcohol;
ii) complex diesters of a polyhydric aliphatic alcohol and a fatty acid containing from eight to vacumned the Athi carbon atoms, while specified complex fluids has at least one hydroxyl group associated with the residue of aliphatic alcohol; and
iii) mixtures of these complex monoamino and diesters; and in which the active ingredient is present in amounts less than about 0.1% weight. fibrous absorbent structure.

7. Absorbent product according to claim 6, in which the branched fibers coated with the active ingredient.

8. Absorbent product according to claim 7, in which the fibrous absorbent structure contains less than about 75 wt%. branched fibers coated with the active ingredient.

9. Absorbent product of claim 8, in which the fibrous absorbent structure contains less than about 50 wt%. branched fibers coated with the active ingredient.

10. Absorbent product according to claim 9, in which the fibrous absorbent structure contains less than about 25 wt%. branched fibers coated with the active ingredient.

11. Absorbent product according to claim 6, in which the active ingredient is present in amounts of less than about 0.05% weight. fibrous absorbent structure.

12. Absorbent product according to claim 6, in which the active ingredient is present in amounts of less than about 0.02% weight. fibrous absorbent structure.

13. Absorbent product according to claim 6, in which the fibrous absorbent structure is and contains less than approximately 0.3% of the ester-soluble substances according to the test on the content of the ester-soluble substances, contains less than approximately 0.7% of water-soluble substances according to the test on the content of water-soluble substances and tested for foaming.

14. Absorbent product intended for the absorption of secretions, such as menstrual periods, blood and Raney exudate containing:
a) a fibrous absorbent structure containing branched fibers;
b) a sufficient amount of active ingredient deposited on the fibers with absorbent structure and effective in inhibition of the synthesis of the toxin toxic shock-1 bacteria Staphylococcus aureus, if the specified product is exposed to these bacteria;
c) a coating containing fibrous absorbent structure, where the active ingredient is chosen from the group consisting of:
i) complex monoamino polyhydric aliphatic alcohols and fatty acids containing from eight to eighteen carbon atoms, with the specified complex monoether has at least one hydroxyl group associated with the residue of aliphatic alcohol;
ii) complex diesters of a polyhydric aliphatic alcohol and a fatty acid containing from eight to eighteen carbon atoms, with the specified complex fluids has at least one hydroxyl group associated with the residue of aliphatic alcohol; and
iii) mixtures at azannyh complex monoamino and diesters; and
in which the active ingredient is present in amounts less than about 0.1% weight. fibrous absorbent structure.

15. Absorbent product according to 14, in which the fibrous structure further includes unbranched fibers, and unbranched fibers coated with the active ingredient.

16. Absorbent product according to 14, in which the branched fibers coated with the active ingredient.



 

Same patents:

FIELD: medicine.

SUBSTANCE: what is described is an absorbent product comprising an odour control material containing at least one inclusion complex of cyclodextrine and an organic compound dispersed in a matrix containing polysiloxane oil.

EFFECT: absorbent product containing the inclusion complex of cyclodextrine and the organic compound in the form that can be easily included in such products and moisture-protected.

9 cl, 1 dwg, 3 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: group of inventions refers to medicine. An antimicrobial composition contains chlorhexidine and pentane-1,5-diol, wherein the amount of chlorhexidine makes 0.000001 to 5 wt %, while the amount of pentane-1,5-diol makes 1 to 75 wt %. The composition is applicable for local administration; it contains a carrier and a gelling material.

EFFECT: group of inventions enables applying the composition for non-therapeutic disinfection, in treating skin infections.

Corn plaster // 2454249

FIELD: medicine.

SUBSTANCE: invention refers to medical and chemical-pharmaceutical industry and is applicable in healthcare facilities and domiciliary for external application as a remedy in skin diseases: corns, plantar callosities, callules. A corn plaster contains salicylic acid, precipitated sulphur, anhydrous lanolin, pine rosin, lump rubber, dimethylsulphoxide, pine resion, petrolatum and agidol with salicylic acid used as micronised particles sized max. 30 mcm, and the ingredients taken in certain proportions. The experimental clinical findings have shown that the leukocytic mass applied on corns has an effect on adjoining skin areas causing no allergy, irritation or redness if the plaster is applied on healthy skin.

EFFECT: corn plaster improves keratolytic, antiseptic and antimycotic properties ensured by qualitative and quantitative composition of the ingredients.

FIELD: medicine.

SUBSTANCE: invention refers to medicine, more specifically to dressing used for closure and treatment of burns, wounds of various aetiology, trophic ulcers, decubitus ulcers, etc. What is described is a bandage in which three components are used: a wound-facing nontraumatic textile layer with antiseptic butole in the concentration 0.05 mg/cm2 to 1.0 mg/cm2 in a therapeutic layer which is coated with a replaceable sorptive layer made of a nonwoven fabric and providing sorption power of the bandage within 15 g/g and 10 g/g once changed. The replaceable sorptive layer is fixed between the therapeutic and sorptive layers by means of an adhesive frame which is a third component, e.g. made of a nonwoven fabric 0.1-0.5 mm thick and 6.0-10.0 mm wide; both surfaces of the frame are coated with a therapeutic adhesive, and an outer size of the framework is equal to a length and a width of the therapeutic layer. The therapeutic layer additionally contains drugs of haemostatic, anaesthetising, antioxidant and/or wound healing action.

EFFECT: production of the sustained-action bandage with extended spectrum of antimicrobial action, improved antimicrobial activity and higher sorption power.

2 cl, 1 tbl

Haemostatic plaster // 2417076

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to medicine, namely to local haemostatic bandaging materials, and can be used in medical and preventive health care facilities. A haemostatic plaster contains a bottom layer of two design versions oriented to contact skin of various sensitivity: supersensitive skin requires thermomelting hypoallergenic non-continuous glue, while skin of moderate sensitivity, a glue of the following composition is used: lump rubber - 12.85 %, synthetic rubber - 12.85 %, pine rosin - 20.35 %, lanolin - 9.9 %, zinc oxide - 32 %, medical mineral oil - 11.3 %, antioxidant additive Agidol - 0.75 %, and a water-absorbing pad fixed on an adhesive layer, made of a nonwoven fabric and impregnated with a haemostatic compound of the following proportions: sodium carboxymethyl cellulose - 0.25-0.4 mg/cm2; calcium chloride - 1.3-1.4 mg/cm2, Furacilin - 0.003-0.005 mg/cm2. The adhesive layer coats the bottom layer either continuously, or in parallel stripes.

EFFECT: provided higher haemostatic properties of the plaster and reduced injures of the patient's skin with pain hypersensitivity threshold.

2 cl, 4 dwg, 2 ex

FIELD: medicine.

SUBSTANCE: invention relates to medicine, more specifically the preparation of extensive long-term non-healing wounds to dermanaplasty requiring the use of plastic split-skin graft. The method consists of applying hemostatic dressings are applied Gemoteks on the wound for 2-3 minutes immediately after surgical treatment on the, in the first stage of wound healing process dressings are used (3-4 days) with the alternation of Atraumatic Tissue Activetex HL, Activetex HF and Activetex HVIT-complex, while on the second stage of wound healing process (2-3 days) tissues Activetex FOM and Activetex FHF are alternated. After the appearance of the boundary epithelialisation and wound cleansing free skin grafting with split-skin graft is performed in accordance with traditional techniques.

EFFECT: invention solves the problem of easier and cheaper method of treatment of extensive long-term non-healing wounds by reducing the time of preparation of the wound surface to dermanaplasty.

2 tbl

FIELD: medicine.

SUBSTANCE: method of obtaining wound bandage material is claimed. Method involves obtaining protein polymer by protein reaction with polyfunctional spacer or its activated derivative. Preferred polyfunctional spacer is polycarboxylic acid, especially dicarboxylic acid. Protein polymers obtained with such spacers can be applied in a wide range of therapeutic purposes, including wound bandage materials, therapeutic agent delivery to organism, and bioadhesive and sealing substances.

EFFECT: obtaining material taking exact shape of wound filling wound hollow completely without irritation of exposable tissues.

27 cl, 2 dwg, 13 tbl, 12 ex

FIELD: medical articles, in particular, self-locking bandages for retention and supporting of soft tissues and fastening of dressings.

SUBSTANCE: self-locking bandage comprises cloth made from mixture of various fibers or 100%-cotton with microdot latex coating. Self-locking bandage is non-allergenic and has good hygienic properties.

EFFECT: simplified structure, reliable usage, and improved ecological safety of self-locking bandage.

1 tbl, 3 ex

FIELD: medicine.

SUBSTANCE: invention relates to coat made of film with openings for absorbent article. Coat is applied with additive combination containing hydrophilic substance and lyophylic substance. Said additive combination makes it possible to improve fluid transport through coat and to reduce friction force in process of turunda production.

EFFECT: improved material for medicine application.

41 cl, 4 tbl

Hemostatic material // 2287333

FIELD: pharmaceutics.

SUBSTANCE: the suggested hemostatic material contains collagen and thrombocytic mass dried due to freeze drying and structured in formaldehyde vapors, moreover, it contains transfusion-unsuitable thrombocytes at the following ratio: collagen : thrombocytes = 100:(0.5-2.5). Additionally, this material may contain antiseptics or antibiotics of wide spectrum of action. The innovation enables to apply thrombocytes after cryodestruction, and, also, transfusion-unsuitable thrombocytes (overdue storage period), that is apply the material which is considered to be useless. The material suggested is of high hemostatic activity.

EFFECT: higher efficiency of application.

11 ex

FIELD: medicine.

SUBSTANCE: invention refers to medical equipment, namely to a drainage system, particularly for aspiration in case of the aspiration treatment of fistulas, surgical wound dehiscences, decubitis ulcers, injuries and other similar damages, such as venous and arterial ulcers or diabetic foot related injuries. The drainage system comprises an aspiration bag carried by a sheet member that can be coupled with a cavitary injury and that is coupled or can be coupled with an aspirator by means of a joint member, and also at least one drainage layer inside the above drainage bag. The above sheet member is used as a carrier for the joint member.

EFFECT: invention makes the treatment and rehabilitation period more comfortable for the patient by ensuring a greater ease of locomotion when draining the fluids with no risk of a direct effect of the joint member on the treated skin causing discomfort, pains and a risk of making the involved skin worse.

13 cl, 17 dwg

FIELD: medicine.

SUBSTANCE: there are described the improved skin adhesive compositions for the attachment of a substrate, such as an absorbent product to the skin. The skin adhesive composition can provide one or more skin effective agents. The skin adhesive composition can be applied on an absorbent product, such as a liner, a hygienic napkin or a product used for incontinence for the direct adhesion of the given product to the user's skin.

EFFECT: skin adhesive composition is characterised by the improved, yet soft adhesion to the user's skin with maintaining the strong and effective attachment to various non-living substrates, other than skin.

14 cl, 3 tbl, 6 dwg, 3 ex

FIELD: chemistry.

SUBSTANCE: disclosed is a respirator, having a laminate capable of reversible adhesion to human skin, having a substrate; an organosilicon mixture attached to the substrate; and an organosilicon adhesive film attached to the organosilicon mixture. The organosilicon mixture is essentially homogeneous and contains a hot-melt organosilicon adhesive with high adhesive power such as Bio-PSA-7-4560, which is solid at room temperature, and a low adhesive power organosilicon adhesive such as Bio-PSA-7-4101, which is a liquid low adhesive power organosilicon material. Also disclosed is a version of the respirator and method of making said respirator.

EFFECT: enabling reversible adhesion of the article to the skin of the user and reliable bonding of the base of the article and the organosilicon mixture.

9 cl, 3 tbl, 6 ex

FIELD: medicine.

SUBSTANCE: invention refers to medicine, more specifically to physiotherapy, otorhinolaryngology, audiology, rehabilitation medicine, and may be used for the physiotherapeutic body exposure in the diseases developed in cerebral and cervical human tissues and organs, such as perceptive hearing loss, siagonantritis, eustachitis, temporomandibular dysfunctional pain syndrome, odontogenous or rhinogenous trifacial neuralgia, Bell's palsy etc. For this purpose, a concha of auricle is exposed to electric current by introducing an electrode into an ear to contact a cavity and cup of concha tightly. Besides, the above are exposed to electric current through an electrode placed into a nasal passage. The electrodes are wrapped in a wet tissue made of a non-woven material with surface density 160-180 g/m2 containing a polymer layer of sodium alginate containing a drug preparation or a mixture thereof. The exposure is generated by direct electric current with its intensity to be gradually increased from 1 to 5 mA. The procedures are sequential at first from one side, and then from the other side. The exposure time makes 10-15 minutes from each side. The therapeutic course is 8-12 daily procedures.

EFFECT: appropriate prescription of the drug preparations enables the method providing the evident analgesic and anti-inflammatory action, activation of the tissue immune processes, improved innervation within the exposure region, recovered locomotor function of the temporomandibular joint and masticatory muscles, higher contractive activity of the muscles of expression, reduced development of any negative responses and complications ensured by the combined action of direct electric current and prolonged action of the pharmacological preparations in the presented tissues.

3 ex

Adhesion cover // 2489141

FIELD: medicine.

SUBSTANCE: invention refers to medicine. What is described is an adhesion cover comprising a body of the adhesion cover with its substrate and adhesion layer on the substrate, wherein the body of the adhesion cover comprises a periphery, a centre and an intermediate portion between the periphery and the centre with the intermediate portion of the body of the adhesion cover having a thickness greater than that of the centre the body of the adhesion cover and the centre of the body of the adhesion cover having a thickness greater than that of the periphery of the body of the adhesion cover; what is also presented is a method for making it. The cover has the adhesion layer retaining its original shape.

EFFECT: improved usability.

10 cl, 1 tbl, 8 ex

Adhesion cover // 2489140

FIELD: medicine.

SUBSTANCE: invention refers to medicine. What is described is an adhesion cover having a substrate, and an adhesion cover formed at least on one surface of the substrate, wherein the adhesion cover has a periphery and a centre; the adhesion layer has voids; the voids in the adhesion layer are localised in the periphery; the adhesion layer in the centre substantially has no voids, while the periphery of the adhesion layer preferentially comprises the voids in the average number of 2.0 to 100 voids/mm3.

EFFECT: adhesion cover is highly resistant to skin separation; there is no easy protrusion of the component of the adhesion layer from an edge of the adhesion cover when stored in a package; inhibited adhesion of the adhesion cover to the inner surface of the package; the adhesion cover can be easily removed from the package and avoided rise of the edges of the adhesion cover caused by cold plastic flow during adhesion to skin.

8 cl, 6 dwg, 1 tbl, 4 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: present invention refers to medicine, namely to pharmaceutical compositions for topical application containing insulin and liposomes. What is described is a pharmaceutical composition for topical application, containing insulin and liposomes in the form of a biofilm having rapid cutaneous penetration, and an ability to reduce blood glucose.

EFFECT: what is presented is the composition having rapid cutaneous penetration.

4 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: present invention refers to medicine, namely to pharmaceutical compositions for topical application. What is described is a pharmaceutical composition for topical application, containing insulin and liposomes bound thereto containing hydrated lecithines in a combination with cholesterol in the form of a plaste having rapid cutaneous penetration, and an ability to reduce blood glucose.

EFFECT: usability and ease of dosing.

4 ex

FIELD: medicine.

SUBSTANCE: invention relates to medicine. Described is system of transdermal delivery of medication for passive transdermal delivery of one or more than one ionised active agent onto biological surface of subject. System of transdermal medication delivery includes carrying substrate and layer of active agent. Layer of active agent includes thickening agent, plasticiser and therapeutically efficient quantity of ionised active agent.

EFFECT: claimed is novel system of transdermal medication delivery for passive transdermal delivery of one or more than one ionised active agent onto biological surface of subject.

23 cl, 32 dwg, 7 ex

FIELD: medicine.

SUBSTANCE: group of inventions relates to medicine. In all versions bandage of lower pressure for application of treatment with lower pressure of tissue section contains interface layer, made with possibility of placement of tissue section. Hygroscopic layer for absorption of liquid from, at least, one of: interface layer and tissue section is in flowing connection with interface layer. Pump for supplying lower pressure to tissue section is in flowing connection with hygroscopic layer. Covering for supporting lower pressure on tissue section is located above pump, hygroscopic layer and interface layer, separator liquid-air for prevention of liquid supply into pump is placed between hygroscopic layer and pump.

EFFECT: claimed are bandage and method of application of lower pressure to tissue section.

65 cl, 20 dwg

FIELD: medicine.

SUBSTANCE: material has two layers - the first one and the second one. The first one has staple viscose fibers. The second one is manufactured from staple easily fusible thermoplastic synthetic fibers. Both layers are joined to each other under water jet treatment. The second layer fibers partially penetrate into the first layer and fixed therein. The second layer surface is melted and turned outward. It becomes smooth under temperature and pressure treatment. The non-woven material has high absorbing capacity.

EFFECT: low risk of traumatic complications.

5 cl, 2 dwg

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