FR2518408A1 - COMPOSITION FOR INTIMATE FEMALE HYGIENE, ESPECIALLY FOR VAGINAL SHOWERS - Google Patents

Abstract

THE INVENTION RELATES TO BODY HYGIENE. IT CONCERNS A COMPOSITION FOR FEMININE INTIMATE HYGIENE, CHARACTERIZED IN THAT IT INCLUDES: A. AN AGENT WHICH EXERCISES A SPECIFIC ANTISEPTIC ACTION ON PATHOGENIC GERMS BUT NOT ON LACTOBACILLUS ACIDOPHILUS; AND B. A NUTRITIVE SUBSTANCE FOR THE SAME LACTOBACILLUS ACIDOPHILUS. USE BY FEMALE PERSONS.

Description

The invention relates to a composition specially

  created for the intimate physiological feminine hygiene.

  It is well known that the vaginal bacterial flora

  is very complex and its qualitative and quantitative composition varies with age. The vulva of the new-

  female born is sterile; in fact, the microorganisms

  after 7 to 8 hours and the microbial flora

  becomes rich and varied (aerobic, anaerobic, pseudo-

  diphtheria, coliforms, bacilli and vaginal yeasts).

  The vagina of the newborn is also sterile and here, the first microorganisms appear between 12 and 24 hours after birth The first to appear are

  staphylococci and diphtheroids which are usually

  replaced by a population of Bacillus

leino

  The bacilli of Doderlein, named after their

  are gram +, non-sporogenic, microaerophilic and anaerobic bacilli with nutritional requirements

  particulars (acetate, mevalonic acid, peptides and

unsaturated fats).

  According to current knowledge, we can identify

  the bacillus of Doderlein as Lactobacillus.

  acidophilus or mixtures of it and other lactobacilli (Lo casei, Lo fermentum etc.) which are mostly homofermentative These bacilli find their

  source of energy in the anaerobic fermentation of

  cres (hexoses) with the formation of 85 to 95% lactic acid

  that more small amounts of C 02 and acetic acid

  If heterofermentative lactobacilli are also

  present in the vagina, less lactic acid is formed

  that (50%) and the rest of the sugars is reduced to alcohol,

  acetic acid, formic acid and 002.

  The bacillus of Doderlein is considered the most characteristic of the whole "indigenous" microsystem

  which regulates the values of the local concentration.

  hydrogen ions (p H 5,8 + 0,2) in women.

  incorrect use of vaginal douches based on disinfectants

  and sometimes also have an inappropriate

  the destruction of Lactobacillus acidophilus and

  therefore to a qualitative and quantitative alteration

  native and native vaginal flora, which can cause serious inconvenience and

  an abnormal flora and often pathogenic.

  According to the invention, the composition is based on

  acidic and contains specific nutrients

  lactobacilli (dextrose and unsaturated fatty acids)

  res) and a bacterial deterrent which has no effect on lactobacilli In particular, the composition according to the invention consists of:

  (1) an agent that exerts a specific antiseptic action

  only on pathogenic germs but not on Lactobacillus

  acidophilus, and (2) a nutrient for this same Lactobacillus acidophiluso

  This composition allows anaerobic fermentation

  optimum for Lactobacillus acidophilus with a strong

  lactic acid production and gives rise to a bac-

  transient teriostatics on other micro-species

  The following are examples of antiseptic agents useful in the composition of the invention: acetic, lactic and mevalonic acids, preferably buffered at a pH equivalent to the physiological range. Examples of nutrients are :

  monosaccharides and disaccharides, used individually

  jointly or jointly, so as to provide, in the

  vaginal environment, the source of energy required for

  anaerobic treatment; unsaturated fatty acids, used alone or in mixtures;

  an association of the above classes of nu-

tritives.

  For additional benefits, composi-

  of the invention, especially when it is used

  in the form of a vaginal douche, will contain a mixture of unsaturated fatty acids with strong surface-active characteristics; in this way, the nutrient component also provides a detergent function desirable in a composition of this type.

  The examples below show some of the

according to the invention.

Example 1

  To prepare a single dose of solution for

  shower for internal use, the following composition is used:

  te: sodium acetate trihydrate 2.5 g glacial acetic acid 0.12 g anhydrous glucose 1.0 g polysorbate 80 1.5 g perfume 0.02 g distilled water to make 100 ml The pH of the solution is 5, 71 o

Example 2

  To prepare a single dose of solution for

  shower for internal use, the following composition is used:

  te: sodium acetate trihydrate 2.5 g 85% lactic acid 0.14 g anhydrous glucose 1.0 g polysorbitan monooleate 1.50 g perfume 0.02 g distilled water to make 100 ml The pH of the solution is of 6.2 Example 3

  To prepare a single dose of solution for

  For external use, the following composition is used: sodium acetate trihydrate 5 g glacial acetic acid (d = 1.05) 0.24 g anhydrous glucose 2.0 g polysorbate 80 3.0 g perfume 0.04 g distilled water to make 100 ml

The pH of the solution is 5.8.

Example 4

  With each of the solutions of Examples 1 to 3, sheets of cellulose wadding or the like are imbibed.

for the intimate feminine use.

  With the solution prepared according to Example 1, the following experiments were carried out: (a) In Vitro Antimicrobial Action Tests Table 1 presents activity data.

  antimicrobial solution; the data is expressed

  because of the contact time required for the destruction

tion of testeso microorganisms

  Table 2 presents the same data concerning

  tests carried out in the presence of serum

  ra that in the presence of organic substances, the time of

  contact is prolonged, but only to a lesser extent

nime. b) Systemic toxicity

  Repeated topical administration of the product

  both rats (45 days) and subjects

  humans (10 days) shows the absence of any systemic

  The rats do not undergo any change in growth.

  have no mortality

  Tables 3 and 4 show hemostatic values

  logical and hemochemical in rats at the end of the

  treatment period and those in the control group.

  Table 5 shows the same values for human volunteers There are no variations

  significant haematological and hemochemical parameters

  The examination of the urine, carried out at the end of

  nor does it show any factors worthy of mention.

  your. c) Demonstration of the absence of systemic effects

  During repeated administration of the product

  45 days by topical application to shaved skin

  and scarified rats, we do not observe any principles

251840 l

  in the serum of animals The same results are obtained

  results after treatment of human volunteers by the shower of the example lo In conclusion, the experiments

  show optimal results with regard to the ef-

  the effectiveness of the solution according to the invention, for use as an internal and external shower, and therefore

  also for products soaked in the same solution.

  In particular, this solution shows a high level of

  thanks to antimicrobial activity against gram + and gram germs examined, without hindering the development of lactobacilli.

Table 1

  Antimicrobial activity of the solution contact time (expressed in minutes) Microorganisms QS 1 2 as a function of

10 2 O 30

  Staphylococcus aureus Staphylococcus aureus Streptococcus faecalis Streptococcus faecalis Streptococcus faecalis E coli E coli Salmonella typhi Ps aeruginosa Ps aeruginosa Ps aeruginosa Lactobacillus acidophilus Lactobacillus acidophilus Lactobacillus acidophilus

1 + + +

2 + + +

1 + + +

2 + + +

3 + + +

1 + + +

2 + + +

1 + + +

1 + + +

2 + + +

3 + + +

1 + + +

2 + + +

3 + + +

+ + + +

+ + + +

+ + + +

_ S

Table 2

  Antimicrobial activity of the solution as a function of

  contact time (expressed in minutes) in the presence of

  rum (20%) Microorganisms 1/2 J 2 5 10 20 30 Staphylococcus aureus 1 Staphylococcus aureus 2 + + + + Streptococcus faecalis 1 + + + + Streptococcus faecalis 2 + + + + Streptococcus faecalis 3 + + + + E Coli 1 E coli 2 - + + + + Salmonella ty Di 1 + -P aeruginosa i + + + 4+ Ps aeruginosa 2 + Ps aeruginosa 5 + + + + Lactobacillus acidopb ilus 1 + Lactobacillus acidophilus 2 + Lactobacillus acidophilus 3 + +

TABLE 3

  11 EMATOLOGICAL AND IOENATOCHIM VALUES OF RATPS TREATED BY THE SOLUTION

I 2 5 4 7 89

  ERYTHROOYTES HENOGLOBIN LEUKOCYTES FORMUR GLUCOSE NITROGEN PROTEINS GOT GP?

103 LEUCOCYT AREA TOTALS

  106 / mm 3 g / b 00 mi 10 / MM NEBL mg 100 / ml mg 100 / ml g 10 m Um Um

  I 6.6 14.7 10.4 26 O I 70 4 88 20 6.10 59.9 20.0

  2 7.0 15.6 10.0 23 I O 72 4 82 22 6.4 55.0 1610

  3 8.8 14.65 10.1 23 O I 74 2 93 23 695 56.0 1990

  4 6.4 15.4 10.6 24 O O 76 O 80 29 6.2 60.0 20.0

  7.0 15.9 10.4 25 1 O 73 O 68 29 6.91 64,) 0 22.0 O

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Claims (10)

  Composition for feminine intimate hygiene, characterized in that it comprises:   (a) an agent that has a specific antiseptic action   only on pathogenic germs but not on Lactobacillus acidophilus and (b) a nutrient for this same Lactobacillus acidophilus.   2 Composition according to claim 1,   characterized in that the agent exerting the antiseptic action   specific is the acetic acid / acetic acid system sodium tate.   3 Composition according to claim 1,   characterized in that the agent exercising the antisep-   Specific tick is the lactic acid / buffer system sodium acetate.   Composition according to Claim 1, characterized in that the nutritive substance is formed   monosaccharides and disaccharides, used individually   The composition according to claim 1, characterized in that the nutritive substance is formed.   of unsaturated fatty acids used individually or in combination jointemento   6 Composition according to claim 4, characterized   characterized in that the nutrient is glucose.   Composition according to claim 5, characterized   in that the unsaturated fatty acid nutrient also has   surfactant characteristics.   8 Composition according to claim 7, characterized   characterized in that the unsaturated, nutritious fatty acid is Polysorbate 80   9 Composition according to any one of the   Claims 1 to 8, characterized in that the substance   nutritive is a mixture of monosaccharides and   charides with unsaturated fatty acids   The composition according to claim 9, wherein   characterized in that the nutrient is a mixture 2518 40 It of glucose and Polysorbate 80.   llo Use of a composition according to the   voucher 1 in the form of a vaginal douche internal or external age.   O Use of a composition according to the   in the form of a solution serving to   to pre-saturate cellulose wadding sheets or the like for feminine hygiene.