PRODUCTION METHOD THEREOF

Technical Field

The present invention relates to a combination of multi-probiotic oils developed for use in health and food sector consumed as a food supplement and preventive food to be used as a therapeutic and/or inhibitor for the treatment of infertility, vaginal infection regression, dermal pH regulation (male/female).

The present invention particularly relates to Lactobacillus rhamnosus, Lactobacillus gasseri, Lactobacillus acidophilus, Lactobacillus delbrueckii, Lactobacillus fermentus, Lactobacillus casei, Lactobacillus brevis, Lactobacillus equi, Bifidobacterium animalis, Bifidobacterium bifidum, Bifidobacterium infantis, probiotic bacteria and multi-probiotic oil combination containing calendula oil, geranium oil, lemon oil and production method thereof.

State of the Art

Recently, as a result of the increased awareness of consumers, the trend regarding health protection by means of nutrition has increased. This condition has revealed the term functional food and its industry. Functional foods are shortly defined as "foods that positively affect health in addition to their nutritional value". Today, foods or supplements containing probiotics establish a substantial part of this sector.

Probiotics use nutrients by attaching to intestinal surfaces and creating an ecological environment for themselves and thus they restrict the development of pathogens by creating a competitive environment. Furthermore, they prevent the growth of other harmful bacteria by producing various organic acids such as acetic acid and lactic acid, lowering the pH, producing bacteriocins and hydrogen peroxide under certain conditions. The positive effect of probiotics is not limited with the gastrointestinal system, but it is known that they also provide various nutritional and therapeutic effects. It increases the bioavailability of lipids and proteins by means of the enzymatic hydrolysis that occurs with the participation of these bacteria and they reduce the allergenic property and effect of foods. For example, they can digest lactose and reduce the symptoms caused by lactose intolerance by lowering the level of lactose in fermented dairy products. Furthermore, probiotics are effective in lowering serum cholesterol level, in the treatment and prevention of diarrhea, in the control of Helicobacter pylori infection and inflammatory bowel disease, they also show various anticarcinogenic and antimutagenic effects. It has been reported that probiotics have positive effects in the healing process of wounds, and probiotic use in babies reduces diarrhea, colic pain, allergic diseases and respiratory disorders and strengthens the immune system according to the findings.

Today, although aromatic oils and probiotic contents are used in health, food and cosmetics sectors, there are not enough studies regarding their use in combination. There are various dermo-cosmetic and odour treatment areas where aromatic oils are used. In this field, edible oils are consumed as food supplements because of their rich content. Furthermore, it is also used in psychosocial cosmetic therapies due to its pleasant odor property. Probiotic ingredients are also widely consumed as food supplements. Some beneficial bacteria and/or yeast combinations are used as drugs for intestinal diseases. Flowever, although there are formulas available to prevent the formation of gastrointestinal (digestive system) disorders caused by nutritional habits of today, they were insufficient.

Multi-probiotical oil combination of calendula oil, geranium oil, and lemon oil was deemed applicable as a preventative approach and / or inhibitor for infertility treatment, vaginal infection regression, dermal pH regulation (male / female).

The family of beneficial bacteria in the content of selected probiotic combination, the metabolic, gynaecological, dermal and age-related diseases that occur in their deficiencies have been the subject of many studies. There are many studies regarding brain-intestinal line, but the treatments aimed at eliminating the deficiencies in this line have been limited to chemical approaches.

The following applications are encountered in the literature regarding the subject matter.

In the patent application numbered TR 2013/13009 with the title "Probiotic lactobacillus strains for enhanced vaginal health"; the interaction of Lactobacillus plantarum, Lactobacillus crispatus and Lactobacillus gasseri, especially with the vagina, vaginal epithelium and microbial flora, particularly maintains the pH acidity level in the vagina, and are combined in a formulation used in the treatment of bacterial vaginosis, viral vaginosis, yeast vaginitis, infections in the vagina, sexually transmitted diseases such as HIV and chlamydia, infections endangering the fetus in pregnant women, preterm labor and urinary tract infections.

Patent application numbered TR 2019/07851 with the title “Lactobacillus rhamnosus bacteria for the treatment of for example bacterial vaginosis.” relates to a lactic acid Lactobacillus rhamnosus bacteria suitable for the treatment of bacterial vaginosis. The invention aims to provide the Lactobacillus rhamnosus strain with a dietetic or pharmaceutical composition for the treatment of vaginal and female genital and urogenital infections and/or urinary tract infections caused by Lactobacillus rhamnosus deficiency.

Another invention is the patent application numbered TR 2013/14095 with title "Preparation containing probiotic bacteria and fish oil". Proposed invention is a probiotic preparation consisting of a powder mixture containing Bifidobacterium Infantis, Bifidobacterium breve and LactobasHlus acidophilus probiotic bacteria, which is used by pouring vial liquid containing inulin and the proposed liquid in it, to be used in the elimination of probiotic deficiency and in the proper functioning of children's mental development, strengthening of nervous systems, eye development and energy metabolism, important property of this preparation is proposed vial liquid contains fish oil containing Omega-3 fatty acids.

As a result, due to the abovementioned disadvantages and the insufficiency of the current solutions regarding the subject matter, a development is required to be made in the relevant technical field.

Brief Description of the Invention

The present invention is related to multi probiotic and oil combination which fulfils the abovementioned requirements, eliminate all disadvantages and bring additional advantages.

The primary object of the invention is to provide a probiotic and oil combination that is consumed as a supplementary and preventive food to be used as therapeutic and/or preventive treatment for infertility, vaginal infection regression, dermal pH regulation (male/female) ", and that is developed for use in health sector.

An object of the invention is to present Lactobacillus rhamnosus, Lactobacillus gasseri, Lactobacillus acidophilus, Lactobacillus delbrueckii, Lactobacillus fermentus, Lactobacillus casei, Lactobacillus brevis, Lactobacillus equi, Bifidobacterium animalis, Bifidobacterium bifidum, Bifidobacterium infantis, probiotic bacteria and multi-probiotic oil combination containing calendula oil, geranium oil, lemon oil.

Another object of the invention is to be used as a supportive treatment of sperm or egg-induced infertility and pre-pregnancy preparation, regression of various bacterial, viral or fungal-origin urogenital infections, provision of dermal pH regulation (male / female), and to act as a preventive/inhibitor for metabolic, gynecological, dermal and age-related diseases, as a therapeutic agent and as a supplementary in preventive medicine. Another aim of the invention is to provide a probiotic product that has no adverse side effects and does not contain harmful chemicals and contributes to human health.

In order to achieve the aforementioned objects, the invention is a multi-probiotic oil combination of calendula oil, geranium oil, lemon oil developed for use in health and food sector as a therapeutic and/or inhibitor for the treatment of infertility, vaginal infection, dermal pH regulation (male/female); and includes Lactobacillus rhamnosus, Lactobacillus gasseri, Lactobacillus acidophilus, Lactobacillus delbrueckii, Lactobacillus fermentus, Lactobacillus casei, Lactobacillus brevis, Lactobacillus equi, Bifidobacterium animalis, Bifidobacterium bifidum, Bifidobacterium infantis probiotic bacteria and calendula oil, geranium oil, lemon oil.

The structural and characteristic features of the present invention will be understood clearly by the following detailed description and therefore the evaluation shall be made by taking the detailed description into consideration. Detailed Description of the Invention

In this detailed description, the inventive multi probiotic oil combination is described only for clarifying the subject matter in a manner such that no limiting effect is created.

The present invention relates to a multi-probiotic oil combination containing Lactobacillus rhamnosus, Lactobacillus gasseri, Lactobacillus acidophilus, Lactobacillus delbrueckii, Lactobacillus fermentus, Lactobacillus casei, Lactobacillus brevis, Lactobacillus equi, Bifidobacterium animalis, Bifidobacteriim bifidum, Bifidobacterium infantis, probiotic bacteria and calendula oil, as fixed oil, geranium oil, as essential oil, and lemon oil - collectively, the oil conductors - to be used in health and food sector as a preventive and/or inhibitor for the treatment of infertility, vaginal infection regression, dermal pH regulation (male/female), and the production method thereof.

Calendula oil ( Calendula officinalis) contains saponin, carotene, lycopine, neolycopine, citroxanthin, violaxanthin, sterol, flavonite, oleic acid, linoleic acid, stearic acid, palmitic acid, hrintaxanthin, and etheric oil. Calendula oil, an antiseptic agent, contains anti-inflammatory and antibacterial properties. It can be used in dermatological diseases thanks to its antifungal property. It has a regulatory effect on the intestine and digestive system. Calendula oil is also used for the treatment of other health problems such as conjunctivitis and irregular menstrual cycle menstrual pain, depurative, etc.

Essential oils and aromatic extracts are used in the perfume and flavour industry, in perfumes, food additives, cleaning products, cosmetics and pharmaceutical preparations, as a source of aroma chemicals or as a starting source in the synthesis of nature-identical and semi-synthetic flavour preparates. Aromatherapy is particularly used for indigestion problems, skin diseases, headaches, insomnia, stress, cancer treatment, and improving mental perception. In addition to the antibacterial and antifungal effects of essential oils and aroma extracts, they have also effects on the nervous system, digestive system, immune system and respiratory system. Calendula oil, geranium oil and lemon oil used in health and cosmetic industries as essential oils. Table 1. Inventive multi probiotic oil combination content

The present invention contains in total weight, 95-97% calendula oil, 0.21 -0.23% geranium oil, 0.19-0.21% lemon oil, 0.450-0.550% Lactobacillus rhamnosus, 0.150- 0.250% Lactobacillus gasseri, 0.150-0.250% Lactobacillus acidophilus, 0.450- 0.550% Lactobacillus delbrueckii, 0.150-0.250% Lactobacillus fermentus, 0.150 - 0.250% Lactobacillus casei, 0.150 - 0.250% Lactobacillus brevis, 0.150% - 0.250% Lactobacillus equi, 0.350 - 0.450% Bifidobacterium animalis, 0.150 - 0.250% Bifidobacterium bifidum, 0.150 - 0.250% Bifidobacterium infantis in the whole mixture.

Preferred sample of the invention includes 96.5732% calendula oil, 0.22% geranium oil, 0.208% lemon oil, 0.5% Lactobacillus rhamnosus, 0.2% Lactobacillus gasseri, 0.2% Lactobacillus acidophilus, 0.5% Lactobacillus delbrueckii, 0.2% Lactobacillus fermentus, 0.2% Lactobacillus casei, 0.2% Lactobacillus brevis, 0.2% Lactobacillus equi, 0.4% Bifidobacterium animalis, 0.2% Bifidobacterium bifidum, 0.2% Bifidobacterium infantis in the whole mixture.

The inventive probiotic and oil combination and production method comprises the following process steps;

- Isolating microorganisms in sterile area at 22°C - 45°C temperature, 35-75% humidity and 2 -12 days interval and purifying isolates, homogeneously mixing with trihalose, maltodextrin, platinose, cyclodextrin, dextrose and all kinds of 6-carbon sugar and all prebiotic fibers in the bioreactor,

- Freeze drying of microorganisms in a freezer-freezer lyophilizer in a sterile area for 1 - 5 days at a temperature between -80°C and -20°C,

- Mixing the microorganism combination in the cubic mixer,

- Adding geranium and lemon oils in the calendula oil, - Adding Lactobacillus rhamnosus, Lactobacillus gasseri, Lactobacillus acidophilus, Lactobacillus delbrueckii, Lactobacillus fermentus, Lactobacillus casei, Lactobacillus brevis, Lactobacillus equi, Bifidobacterium animalis, Bifidobacterium bifidum, Bifidobacterium inf antis bacteria to the oil mixture in sterile conditions between 1 -5 days and homogenizing the mixture thereof,

- Filling of probiotic and oil combination into amber glass bottles with a peristaltic pump

Filled bottles are kept for 72 hours at 25°C for physical control before packaging.

The most ideal working environment of the probiotic combination in the invention is the essential and fixed oil mixture as detailed above. These elements are the original and sustainable characteristics of the invention and have an important contribution to the invention process since they have not been made previously. The relevant invention will be used as a therapeutic agent and a supplement in preventive medicine, acting as a preventive and/or inhibitor proposed for infertility treatment, vaginal infection regression, dermal pH regulation (male / female).

It is prescribed that individuals who are allergic to any ingredient contained in the invention should not use it. It has no known side effects. It can be consumed 1 -2 times a day in the range of 5-10 ml hungry/full. The product is recommended to be consumed in the afternoon. Any bulges, unusual odours and similar situations in the product shall be reported to the authorized persons. The invention can be used until the disorders are eliminated and subsequently can be used for prophylaxis (protective).