Herbal compounds and methods for treating infections, vulvovaginal and pelvic organ inflammation

By using herbal disinfectant compositions, including extracts from medicinal watermelon, myrrh, myrrh, myrrh and rose plants, the side effects of existing chemotherapy for treating vulvovaginitis were solved, and effective treatment was achieved and restore normal bacterial balance.

CN115066250BActive Publication Date: 2025-02-18BANOOYE ARMAGHAN TEB
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Patent Information

Application Number
CN202080087372.6
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Priority Date
2019-12-15
Filing Date
2020-06-09
Publication Date
2025-02-18
Estimated Expiration
2040-06-09

AI Technical Summary

Technical Problem

Existing chemotherapy treatments for vulvovaginitis have side effects, such as recurrence, drug resistance, disruption of normal bacterial balance and systemic absorption, leading to discomfort in other organs.

Method used

A herbal disinfectant composition, including extracts from medicinal watermelon, myrrh, myrrh, myrrh and rose plants, is used to inhibit or stop the growth of vaginitis-related microorganisms and restore normal vaginal flora.

Benefits of technology

Effectively treat vulvovaginitis, inhibit infection, restore normal bacterial balance, reduce the risk of recurrence, and avoid systemic absorption side effects. It is suitable for treating infections and inflammation of vaginal and pelvic organs.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present disclosure relates to a pharmaceutical composition comprising a group of herbal compositions and to a method of treating diseases or conditions for caring for the vagina and pelvic organs of women or treating different types of infections associated with these parts. The method comprises administering an effective amount of a herbal disinfectant composition to a subject, wherein the herbal disinfectant composition comprises at least one or more plants from the genus Citrus grandis, Myrrh, Myrtle or / and Rosa, or a combination of these plants. The herbal disinfectant composition may be injected into the vagina through a fiber envelope; the fiber envelope may comprise a cylinder, a string having two ends, the string may be connected to the cylinder from one end and a middle portion, the middle portion may be used to retain the herbal disinfectant composition.
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Description

[0001] This published application claims priority over pending Iranian invention patent application No. 139850140003008438, registered on December 15, 2019, entitled "Herbal Combination for the Treatment of Female Infections, Vulvovaginal and Pelvic Organ Inflammations", which is fully incorporated herein by reference. Technical Field

[0002] The present application relates to herbal compounds and methods of use thereof for treating vulvovaginitis, restoring normal vulvovaginal flora, treating vaginal-related diseases, and inhibiting infection or inflammation of pelvic organs. Background Art

[0003] Vulvovaginitis is an inflammation of the lower genitals that affects the vagina and vulva. These inflammatory symptoms include abnormal vaginal discharge, odor, itching and / or discomfort. Vulvovaginitis is mainly caused by bacteria or fungi. Infections caused by protozoa (mainly Trichomonas vaginitis) only account for 10% of these infections. Bacterial infections account for about 50% to 60% of all vulvovaginitis. The most common microorganisms observed in this type of infection (inflammation) include Gardnerella vaginalis, Gardnerella mobiluncus, Chlamydia trachomatis, Mycoplasma hominis, Peptostreptococcus or Ureaplasma urealyticum.

[0004] Approximately 70% of women will have a vulvovaginal fungal infection during their lifetime. In addition, approximately 40% of women with a vulvovaginal bacterial infection will develop a yeast infection. Bacterial and protozoal infections are mainly treated with antibiotics and antiparasitic drugs from the nitroimidazole family such as metronidazole. Fungal infections are usually treated with antifungals from the imidazole-derived drug family such as econazole, miconazole and fluconazole. Despite all the above-mentioned drug treatment modalities, statistics show that half of women treated for a vulvovaginal bacterial infection will be infected again within the next 12 months. It is important to mention that antibiotics used to treat infections in women often lead to a disruption of the normal flora that protects the vaginal area, which can lead to recurrence of the infection. Therefore, the management of Candida infections strongly requires the introduction of new drugs with antifungal properties.

[0005] Therefore, according to the above points, the existing chemotherapy for vulvovaginitis and other diseases of the female pelvic organs is mostly unsatisfactory and causes various side effects including, recurrence, development of drug resistance, disruption of the balance of normal flora, and discomfort of other organs such as stomach, intestines and liver due to systemic absorption of drugs. Therefore, the research on active ingredients, including natural or herbal ones, can be a good solution to this problem.

[0006] Some natural or herbal remedies can exhibit different and sometimes undesirable symptoms at high doses or when used directly for treatment. To address the above problems, a combination (drug) and prescription approach for vulvovaginitis and other diseases of the female pelvic organs is needed. Summary of the invention

[0007] This summary is intended to summarize the subject matter of the present disclosure, and is not intended to identify the basic and critical elements of the subject matter, nor is it intended to determine the scope of the so-called implementation. The proper scope of the present disclosure can be determined from the following detailed explanation and map.

[0008] In a general sense, the present disclosure discloses an exemplary method for treating vaginitis in a subject, controlling vaginitis (vulvovaginitis), restoring normal flora of the vulvovaginal region, or preventing infection and inflammation of other organs. The method may involve administering to the subject an effective amount of an herbal disinfectant compound, wherein the herbal disinfectant composition may include at least one or more plants from the genera Citrus grandis, Myrrh, Myrtle, and / or Rosa, or a combination of these plants.

[0009] All of the above may have one or more of the following characteristics. For example, the main combination of the herbal disinfectant composition may include 50-30% by weight of Citrus aurantium, 50-20% by weight of Commiphora, 50-30% by weight of Myrtle and 50-20% by weight of Rosa. For example, the herbal disinfectant composition may be in the form of a powder, granules or particles. It can also be said that using an effective amount of the herbal disinfectant composition may include applying an effective amount of the herbal disinfectant in a vaginal form to the vagina or a portion of the vagina of a subject. In experiments, the vaginal form may include a fiber bag. In experiments, the subject may be a human. Also, inhibiting vaginitis (vulvovaginitis) may involve inhibiting or stopping the growth of at least one microorganism, and the microorganism may include Trichomonas vaginalis, Candida albicans, Gardnerella vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae or herpes simplex virus. In experiments, vaginal diseases may include vaginitis, vaginal discharge, gonorrhea, bacterial vaginitis, sexually transmitted diseases, atrophic vaginitis, fungal infections or condyloma acuminatum. The effective amount may be for at least one course of treatment comprising at least once a day for at least 14 days.

[0010] From another aspect, the present disclosure mentions a herbal disinfectant composition. The herbal disinfectant composition may include watermelon, myrrh, myrtle and rose. All of the above may have one or more of the following characteristics. For example, the main combination of the herbal disinfectant composition may include 50-30% by weight of watermelon, 50-20% by weight of myrrh, 50-30% by weight of myrtle and 50-20% by weight of rose. In one experiment, the herbal disinfectant composition may include the fruit of the watermelon plant, at least one rose or a mixture of flowers, buds, petals or stems, at least one myrrh or a mixture of its leaves, fruits or gums, and a mixture of myrtle or its leaves and fruits. The herbal disinfectant composition may also contain a carrier drug including a liquid filler or a solid filler, a stabilizer, a dispersant, a suspending agent, a diluent, an excipient, a stabilizer, a solvent or a trap.

[0011] From another aspect, the disclosed application also mentions a fiber bag for opening herbs. The fiber bag may include a cylinder, a string at two ends, the string can be connected to the cylinder from one end and a middle part, and the middle part can be used to retain the herbs.

[0012] All of the above may have one or more of the following features. The herbal medicine may contain a mixture of dry herbs including, 30-50% by weight of plants from the genus Citrus, 50-20% by weight of Commiphora, 50-30% by weight of Myrtle and 50-20% by weight of Rosa. Also, the herbal disinfectant composition may be in the form of a powder, granules or particles. In one experiment, the cylinder may be composed of non-woven fibers or single or multiple layers of woven fibers. For example, the cylinder may be a simple form, non-fluff, low-fluff and high-fluff forms of woven fibers. Also, the cylinder may be cone, cylinder, sphere, round, pearl, bullet or teardrop shaped. The fiber package may also include an applicator. The applicator may have a bracket and a handle, and the cylinder may be located in a holder. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] According to the present teachings, the drawn shapes are only used as examples and are not intended to be limiting in showing one or more visualizations. Therefore, the drawn shapes do not limit the scope of the present disclosure. Also, reference numbers with similar shapes show similar or identical elements.

[0014] A1-Figure_This figure shows a schematic diagram of the applicator from a side view and is consistent with one or more embodiments of the presently disclosed application.

[0015] B1-Figure_This figure shows a schematic diagram of the applicator from a top view and is consistent with one or more embodiments of the presently disclosed application.

[0016] A2-Figure_This figure shows a schematic diagram of a fiber package from a side view and is consistent with one or more embodiments of the presently disclosed application.

[0017] B2-Figure_This figure shows a schematic diagram of a fiber package from an opposite view and is consistent with one or more embodiments of the presently disclosed application.

[0018] 3- FIG._ This figure shows the release profiles of herbal disinfectant compounds from four fiber packages including, simple tissue, vertical tissue, low velvet and high velvet tissue, and is consistent with one or more embodiments of the presently disclosed application.

[0019] 4- FIG._ Histological examination of tissue samples prepared from the vagina of control rabbits treated with fiber packs without herbal disinfectant compounds (a, b and c) and microscopic images of rabbits treated with fiber packs including intravaginal herbal disinfectants (d, e and f), in accordance with one or more embodiments of the presently disclosed application.

[0020] Details of the invention

[0021] Many specific details are presented below by way of example to provide a complete understanding of the relevant tutorials. However, it should be disclosed that the present teachings can also be applied without these details. Except for the concepts specifically defined in this disclosure, all technical and scientific terms used refer to the same definitions that can be understood by those skilled in the art (the present disclosure field). Although many similar materials and methods can be used to teach this application, here, we try to mention the best materials and methods for conducting relevant training. The following detailed description is not meant to be limiting, and the scope of the present disclosure is limited only by the contents of the appendix.

[0022] As used in the specification and claims, the singular "a", "an", and "an" include the plural unless the context clearly dictates otherwise.

[0023] Here, the term "disinfectant" may have different meanings including, antibiotic, disinfectant, antifungal, antibacterial, antiprotozoal and antiviral, or other similar terms. These definitions include not only the above examples.

[0024] The terms "antifungal", "antibacterial", "antiprotozoal" or similar terms used in this disclosure refer to stopping the growth of fungal, bacterial, protozoan or viral populations, or reducing the likelihood of the severity of fungal, bacterial, protozoan or viral diseases. These concepts can also be defined as the death of fungi, bacteria or protozoa, or the reduction or control of the pathogenic effects of these fungi, bacteria or protozoa. The terms bactericide and fungicide can be used instead of antibacterial and antifungal terms, respectively. In one or more aspects of the present application, the herbal disinfectant compounds have antibacterial properties. The above-mentioned term antimicrobial agent refers to the effective prevention, inhibition or control of the growth or pathogenic effects of microorganisms. Here, microorganisms refer to any type of bacteria, viruses, fungi or protozoa.

[0025] As used herein, the term "subject" of the methods disclosed herein may include mammals. In a specific embodiment of the present disclosure, the subject refers to a human. In certain aspects of the present invention, the compositions in the present disclosure can be used for human subjects of both sexes or for treating infections and inflammations in men and women.

[0026] As used herein, the term "plant" of the methods disclosed herein may include Citrus aurantium, Commiphora, Myrtle, and Rosa.

[0027] As used herein, the term "effective dose" proposed in the present disclosure refers to a desirable and appropriate amount for antimicrobial activity or disinfection activity in general, and includes, but is not limited to, killing microorganisms or inhibiting microbial infection, inhibiting growth or toxicity. In some embodiments of the present disclosure, the term "effective value" refers to the amount required to reduce or improve at least one symptom of the disease compared to an untreated patient. The effective amount of active substance used in drug treatment of diseases depends on the method of prescribing, the extent of the disease, the stage of the disease, the age, sex, weight and the general health of the subject.

[0028] In the composition and treatment methods proposed in the present disclosure, we have attempted to use a novel combination of selected herbs including, Citrus aurea, Commiphora, Rosa rugosa and Myrtle and use a suitable carrier to deliver the drug to the vaginal mucosa to treat fungal, bacterial, viral and protozoal infections of the vulvovaginal and other extremities including the uterus, vulva and cervix. This method also eliminates deep infections by diluting the vagina, uterus and pelvic organs. Thus, this completely eliminates the infectious and malodorous discharges of the vulvovaginal area and thoroughly cleanses the area in addition to treating the infection.

[0029] In general aspects, a herbal composition having disinfecting properties is provided herein. In general embodiments, the herbal disinfectant composition may contain 10-90% by weight of at least one or more plants of the genus Cucurbita, 10-90% by weight of Commiphora, 10-90% by weight of Myrtle, and 10-90% by weight of Rosa (in the final combination), or a mixture of these herbs. In a specific embodiment, the herbal disinfectant composition may contain 30-50% by weight of at least one or more plants of the genus Cucurbita, 20-50% by weight of Commiphora, 30-50% by weight of Myrtle, and 20-50% by weight of Rosa (in the final combination), or a mixture of these herbs.

[0030] In one or more embodiments, the genus Citrullus includes the medicinal watermelon (Colocynth) from the scientific name Citrullus colocynthis of the Cucurbitaceae family, which grows naturally in arid areas. This large climbing plant may have dill leaves, yellow hermaphroditic flowers, and round green and white fruits that turn yellow when ripe. This plant is commonly grown in countries such as Saudi Arabia, Syria, Jordan, Egypt, Iran, India, and Pakistan. It is named after medicinal watermelon, bitter apple, bitter cucumber, desert gourd, vine of Sodom, egusi, wild gourd, and also called Khazar in southern Iran. The names used in this article are not limited to the above names.

[0031] In one or more embodiments of the present disclosure, the genus Commiphora includes various Commiphora species from the scientific name Commiphora myrrha. The plant is also known as myrrh, African myrrh, herabol myrrh, Somali myrrh, common myrrh, or gum myrrh. The names used herein are not limited to these names. In one or more embodiments, the genus Commiphora may include, Commiphora abyssinica, Commiphora schimperi, Commiphora erythraea, and Commiphora molmol. The names used herein are not limited to these names.

[0032] In one or more embodiments herein, the genus Myrtus includes various species of myrtle from the Myrtaceae family with the scientific name Myrtus communis. This plant is also known as the "common myrtle bush". The plant is a shrub that can grow up to 2 to 3 meters. The stems of this shrub can grow irregularly and may have a soft light brown outer shell. Its leaves may be green, hard, and dark green. The names used herein are not limited to the above names.

[0033] In one or more embodiments of the present disclosure, the genus Rosa includes a genus Rosa with the scientific name Rosadamascene. This plant is also known as rose, Damask rose, hybrid tea rose, French rose, barbed thorn (Rosa moschata), and glandular fruit rose (Rosa fedtschenkoana). The names used herein are not limited to these names.

[0034] In one or more embodiments of the present disclosure, the herbal disinfectant composition can be used to inhibit or stop the growth of at least one of the following microorganisms. These microorganisms may include Trichomonas vaginalis, Candida albicans, Gardnerella vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae or herpes simplex virus.

[0035] In some embodiments, the herbal disinfectant compositions described herein can be used to treat vaginal diseases such as vaginitis, vaginal discharge, gonorrhea, bacterial vaginosis, sexually transmitted diseases, atrophic vaginitis, fungal infections, and condyloma acuminatum.

[0036] In a specific embodiment of the present disclosure, the herbal disinfectant composition with bactericidal effect may include 30-50% by weight of at least one or more plants of the genus Cucurbita, 20-50% by weight of Commiphora, 30-50% by weight of Myrtle, and 20-50% by weight of Rosa (in the last combination), or a mixture of these herbs.

[0037] In one or more embodiments of the present disclosure, the herbal disinfectant composition may include one or more of the following: water-soluble extracts of one or more plants, powders containing at least one or more dried herbs, oil-soluble extracts of one or more plants, powders of one or more plants provided by a spray dryer, powders of extracts in which proteins are hydrolyzed, which may contain extracts of one or more plants, essential oils of one or more plants, active ingredients of one or more plants, powders of peeled fruit centers of one or more plants, extracts of one or more plants encapsulated in liposomes, or extracts of one or more plants not encapsulated in polymers.

[0038] In a specific embodiment, one or more dried plants including, watermelon, myrrh, myrtle or rose can be made into powder. Therefore, in this embodiment, different parts of these plants can be ground.

[0039] In one or more embodiments, to prepare the herbal disinfectant composition, different parts of the plant may be used, including at least one or a mixture of fruits, leaves, stems, roots, flowers, buds, petals, skin tissue, gums, resins or mixtures thereof.

[0040] In one or more embodiments, watermelon fruit can be used to prepare herbal disinfectant compounds.

[0041] In one or more embodiments, the herbal disinfectant composition may be prepared using at least one flower, bud, petal, stem, or a mixture thereof of a rose.

[0042] In one or more embodiments of the present disclosure, at least one or a mixture of Myrtle leaves or fruits may be utilized to prepare the herbal disinfectant composition.

[0043] In one or more embodiments of the present disclosure, at least one or a mixture of leaves, fruits or gums of Myrrha spp. may be utilized to prepare the herbal disinfectant composition.

[0044] In one or more embodiments of the present disclosure, the use of the herbal composition provided in the present disclosure can limit the possibility of recurrence of disease or reinfection due to an imbalance of saprophytic flora. Also, the development of such a compound can not only cure the infection, but also clean the vaginal environment, clearing the vaginal area of ​​secretions, infection and drug residues.

[0045] One embodiment of the present disclosure is directed to preparing herbal antiseptic compounds in vaginal dosage forms including vaginal ointments, vaginal creams, vaginal gels, vaginal fluids, vaginal lotions, vaginal suspensions, vaginal foams, tampons, vaginal tablets, vaginal capsules, vaginal rings, lotions, ovules, vaginal douches, powders, granules, microparticles, aerosols, films, drops, sprays, fiber packs and suppositories.

[0046] In one specific embodiment, preparing the herbal disinfectant composition may include preparing a powder consisting of dried plants including different types of Citrus grandis, Commiphora sinensis, Myrtle or Rosa canadensis. In another specific embodiment disclosed, preparing the herbal disinfectant composition may include preparing a granule, microgranule, set of granules or set of microgranules containing a powder consisting of dried herbs including Citrus grandis, Commiphora sinensis, Myrtle or Rosa canadensis. In one or more embodiments of the present disclosure, the powder consisting of dried plants and / or granules or microgranules including Citrus grandis, Commiphora sinensis, Myrtle or Rosa can be administered to a subject using a fiber bag.

[0047] In various embodiments, the herbal disinfectant composition may be prepared with an acceptable pharmaceutical carrier. A suitable pharmaceutical carrier refers to any acceptable pharmaceutical substance including, liquid or solid fillers, stabilizers, dispersants, suspending agents, diluents, oxidants, thickeners, solvents or sealants, and is used to carry or transfer the compounds or molecules used herein to the body of a subject so that the compounds or molecules can exert the desired activity. In one or more embodiments of the present disclosure, including acceptable drugs, the carrier may include any coating agent, antibacterial or antifungal agent, drug absorption retardant, etc. This must be compatible with the activity of the disclosed herbal disinfectant composition and physiologically acceptable to the subject.

[0048] The herbal disinfectant compositions of the present disclosure can be applied to various surfaces of the body, skin, body cavities or mucous surfaces such as the nose, mouth, eyes, ears, respiratory system, vagina or rectum. Also in some of the disclosed embodiments, the molecules can be administered to the subject in a variety of ways.

[0049] In one or more embodiments of the present disclosure, a method of treating or preventing infection or inflammation of the vulvovaginal or other pelvic organs of a subject or restoring normal vulvovaginal flora may involve administering to the subject an "effective amount" of an herbal disinfectant composition. In some embodiments, the herbal disinfectant composition may contain 10-90% by weight of at least one or more plants of the genus Cucurbita, 10-90% by weight of Commiphora, 10-90% by weight of Myrtus communis, and 10-90% by weight of Rosa (in the final combination), or a mixture of these herbs. In a specific embodiment, the herbal disinfectant composition may contain 30-50% by weight of at least one or more dried plants of the genus Cucurbita, 20-50% by weight of Commiphora, 30-50% by weight of Myrtus communis, and 20-50% by weight of Rosa (in the final combination), or a mixture of these herbs.

[0050] Myrtus communis 30-50% by weight and Rosa rugosa 20-50% by weight (in the final combination), or a mixture of these herbs.

[0051] In one or more embodiments of the present disclosure, the herbal disinfectant composition may be administered vaginally.

[0052] In some embodiments, the effective amount or effective dose of the herbal disinfectant composition for treatment, especially in the form of a group of particles in a fiber bag, can be 0.5 to 10 grams. In one or more embodiments, the effective dose of the herbal disinfectant compound for treatment, especially in the form of a group of particles in a fiber bag, can be especially at least once a day for 10 to 24 hours, and more especially at least once a day for 15 to 24 hours. In a specific embodiment, the treatment of vaginitis may include using the herbal disinfectant composition at least once a day for at least 14 days. In another disclosed embodiment, the treatment of pelvic organ infection and / or inflammation or chronic disease may include using the herbal disinfectant composition at least once a day for at least 14 days (herein referred to as a cycle), especially at least one or several periods, more than 6 to 8 months or longer until a good effect is achieved.

[0053] In another disclosed embodiment, the effective dose for inhibiting infection and / or inflammation of the vulvovaginal or other pelvic organs or restoring normal vulvovaginal flora can be particularly at least once a day for 10-24 hours, more particularly at least once a day for 15-24 hours for less than 4 days.

[0054] In one or more embodiments of the present disclosure, the effective dose of the herbal disinfectant composition is administered to the subject in a powder form depending on the method of administration and the particle size. In one or more embodiments, the effective amount of the herbal disinfectant composition administered to the subject may be in the range of 0.5 to 7 grams, particularly in the range of 2 to 7 grams.

[0055] In one or more embodiments of the present disclosure, the herbal disinfectant composition may be prescribed to a patient using the dosage and duration of the present disclosure that is effective for treating a disease or condition or alleviating the symptoms of the disease. Known reduction methods in scientific literature and texts are used to reduce the dosage and duration of the present invention that is effective for treating a disease or condition or alleviating the symptoms of the disease. The effective dosage of the herbal disinfectant composition required to achieve the therapeutic effect can be determined based on factors such as the patient's disease type, degree, stage, age, weight, sex, etc. The dosage can be adjusted to achieve the best therapeutic effect. For example, the dosage can be reduced over time. In some disclosed embodiments, the prescribed amount of the drug can be divided into several doses of the drug, or the drug can be prescribed by reducing the dosage of the drug over time every day or in a specific time sequence.

[0056] In one or more embodiments of the present disclosure, the herbal disinfectant composition may also include at least one drug or a mixture thereof. These include all antifungal agents, antibacterial agents, antimicrobial agents, antiviral agents, anti-infective agents, spermicides, hormones, antibiotics, analgesics, antitrichomonal agents, antiprotozoal agents, antimycoplasma agents, antiretroviral agents, nucleoside analogs, reverse transcriptase, protease inhibitors, contraceptives, steroids, antiemetics, dyes, flavoring agents, antihistamines, anti-inflammatory agents, antineoplastic agents, antioxidants, vitamins, substances that increase drug absorption, minerals and plant extracts for intravaginal administration, with the goal of intravaginal administration. These drugs and compositions are not limited to all of those described.

[0057] In one or more embodiments of the disclosed invention, a medicament comprising an herbal disinfectant composition may be applied to a target point or area, particularly the vagina. Such medicaments or pharmaceutical products comprising an herbal disinfectant composition may have antiseptic effects such as antifungal, antibacterial, antiprotozoal and antiviral properties as well as properties including cleansing, pH adjustment, prevention of disease progression to chronicity, recurrence of disease or infection, and prevention of an imbalance in normal flora.

[0058] One embodiment of the present disclosure relates to the preparation of a kit comprising a fiber pack for delivering drugs, pharmaceutical products, herbs or herbal disinfectant compositions to a target point or target area, particularly the vagina. The kit can control the drug release and adverse symptoms when administering the herbal medicine in large doses or directly.

[0059] In some embodiments of the present disclosure, Figure 1A and 1B As shown, the kit may include an applicator for easily placing the fiber bag in the vagina by the user. In an exemplary embodiment, the applicator may include a holder 101 and a handle 103. The cylindrical body 301 may be placed in the holder 101 and then placed in the vagina with the help of the handle 103.

[0060] In one embodiment of the present disclosure, Figure 2A and 2B As shown, the kit may include a fiber bag for intravaginal administration. The fiber bag may include a cylindrical body 301, which itself may include: 1- an herbal disinfectant composition, including a plurality of herbal compositions. 2- a rope having two ends, including a first end 303 and a second end 307, wherein the rope may be connected from the first end 303 to the cylinder 301. In an exemplary embodiment, the cylinder 301 may include a middle portion, wherein the middle portion may include herbs such as Nigella sativa, Plantain, Artemisia selengensis, Chamomile, Watermelon, Commiphora, Myrtle, and Rosa damascena.

[0061] In a specific embodiment of the present disclosure, the middle portion may contain an herbal disinfectant composition comprising a mixture of dry plants, particularly in powder form, including plants of the medicinal watermelon plant with 30-50% by weight, the myrrh species with 20-50% by weight, the myrtle species with 30-50% by weight, and the damask rose with 20-50% by weight (in the final combination). In another embodiment of the present disclosure, the cylinder 301 may include a plurality of granules or microparticles of an herbal disinfectant composition, including medicinal watermelon with 30-50% by weight, myrrh with 20-50% by weight, myrtle with 30-50% by weight, and rose with 20-50% by weight, the proportion or composition of these plants being based on the final weight of the granules or microparticles.

[0062] In one or more embodiments of the present disclosure, the cylinder 301 may be composed of fibers or nanofibers made of animal-based materials such as silk or wool; plant-based materials such as cotton, synthetic materials such as polyester, absorbable materials, or mixtures of these materials; therefore, the body may have a diameter of 0.1 to 2.5 cm and a length of 3 to 10 cm, and may be non-woven or woven as a single layer or multiple layers, particularly including 3-6 layers. In another embodiment of the present invention, the length of the cylinder 301 may be between 5 and 10 cm. In one or more embodiments of the present disclosure, the length of the rope connected to the cylinder 301 by the first end 303 may be between 5 and 15 cm. In addition, in multiple embodiments of the present disclosure, the cylinder 301 may be prepared in different shapes such as, but not limited to, conical, cylindrical, spherical, circular, pearl-shaped, bullet-shaped, and teardrop-shaped. The shape and size of the cylinder 301 are not limited to the above.

[0063] In one of the embodiments of the present disclosure, a plurality of particles or microparticles consisting of a drug, herbal disinfectant composition, or herb can be located at the center of the cylinder 301. In another embodiment of the present disclosure, the cylinder 301 can be made of fibers, so that the herb, herbal disinfectant composition, or drug, such as a drug in the form of particles or microparticles, can generally be placed between the fibers of the cylinder 301. In one of the embodiments of the present invention, the fibers can include herbs or herbal disinfectant compositions. In another embodiment, the cylinder 301 can include a tampon containing herbs or herbal disinfectant compositions, which can be located inside the cylinder 301 or at its center. In a specific embodiment of the present disclosure, the fibers can be in a woven annular form and consist of cotton fibers. In other embodiments of the present disclosure, the fibers can be woven into annular, horizontal, or vertical forms. In other embodiments of the present disclosure, the fibers can be non-woven or woven in a simple, non-fluff, low-fluff, or high-fluff form.

[0064] The fiber packages of the present invention can be applied to various surfaces of the body, skin, mucosal surfaces such as the nose, mouth, ears, respiratory system, various ducts of the subject's body, pudendal canal, vagina, rectum, or other organs or systems of the subject's body.

[0065] The present disclosure includes fiber packs containing herbal disinfectant compositions tested on rabbits to study toxicity and inflammatory effects. The fiber packs containing herbal disinfectant compositions were placed in the vagina of the subject group (rabbits) every day for 24 hours each time for a period of 14 days. Three rabbits were tested as negative controls with only fiber packs and no drugs. FIG-4 shows the histological results of samples (glass slides) prepared from vaginal tissues. The results showed that the herbal disinfectant composition, target group (FIG-4, d, e and f) did not cause any significant allergic inflammatory response in these animals compared to the target group (FIG-4, a, b and c). At the same time, the release of the herbal disinfectant composition of 4 fiber packs was investigated including simple weaving, vertical weaving, low-pile weaving and high-pile weaving, indicating that the drug release level was optimal when the fiber pack was vertically woven. In this case, all the components of the drug were released after 20 hours (FIG-3).

[0066] In one or more embodiments of the present disclosure, the herbal disinfectant composition having a pH value suitable for the vaginal environment can lead to a balance in the vaginal environment, thereby preventing the recurrence of diseases, and will not disrupt the balance of normal vaginal flora.

[0067] In one or more embodiments of the present disclosure, since the herbal disinfectant composition is not absorbed systemically and since the composition has no or minimal side effects, complications to other organs of the body do not occur.

[0068] In one or more embodiments of the present disclosure, this method can be used to treat all vaginal-related diseases, including vaginitis, vaginal discharge, gonorrhea, bacterial vaginosis, sexually transmitted diseases, atrophic vaginitis, fungal infections, genital warts, etc.

[0069] In one or more embodiments of the present disclosure, the composition of the particles presented in the present disclosure and the properties of the fiber packaging described result in controlled release of the drug.

[0070] In one or more embodiments of the present disclosure, fibers are used as drug carriers to clean the vagina and pelvic organ environment.

[0071] In one or more embodiments of the present disclosure, use of fibers results in the excretion of secretions, infections, residues, remnants, or medications from the vaginal environment and allows for effective and efficient treatment of vaginal and uterine infections.

[0072] In one or more embodiments of the present disclosure, the herbal disinfectant composition of the present invention, in addition to having antibacterial effects, has good penetration into the depth of the uterus and pelvic organs, and causes the dissolution of infectious and unnatural discharges in the environment and excretes the discharges out of the body. Example

[0073] Example 1: Preparation of herbal disinfectant composition

[0074] Plant species, including citron, myrrh, myrtle, and rose, were first obtained and dried.

[0075] The gum of myrrh, the fruit of watermelon, the leaves of myrtle and the buds of rose are ground using industrial grinders.

[0076] 30% by weight of watermelon fruit powder, 20% by weight of myrrh gum, 30% by weight of myrtle leaves, and 20% by weight of rose buds were mixed.

[0077] A fiber bag made of multi-layer (3-6 layers) cotton fiber with circular vertical weave was prepared, which was 5-10 cm in length, 2-5 cm in area, and cone-shaped. One end of the bag had a rope 8-10 cm long, woven together with the cylinder.

[0078] Place 2-7 grams of the herbal disinfectant composition as a powder into each fiber bag.

[0079] Example 2: Preparation of herbal disinfectant composition

[0080] The powder obtained by mixing 30% by weight of the powder of the fruit of the medicinal watermelon, 20% by weight of the gum of myrrh, 30% by weight of the leaves of myrtle and 20% by weight of the rose buds will be made into granules of 1-5 cm in size. Here, after the granules are prepared, 2-7 grams of the prepared granules are placed in each fiber bag.

[0081] The prepared granules contained 8.5% total ash, 4% acid insoluble ash and 6-6.6% moisture and pH = 3.83. The moisture content of the granules was studied by both direct and azeotropic methods.

[0082] Example 3: Investigation of drug release

[0083] The effects of three patterns on the amount of drug released were investigated. These patterns all relate to the effect of the weaving of the fiber packages on the released content, and include four types of simple weaves, vertical weaves, low-pilled weaves, and high-pilled weaves. To conduct this test, the fiber packages containing the drug were placed in a buffer solution at a temperature of 37°C in a stability test chamber instrument, and the pH of the buffer solution was close to the pH of the vagina (pH≈4). Samples were taken from the buffer solution within 5-24 hours, and the content of the active agent of the drug watermelon called colocynthis was measured using an HPLC method ( Figure 3 ). The results showed that the packaging woven using the vertical weaving method resulted in the highest drug release. Using this weaving method, all components of the drug were released into the environment after 20 hours.

[0084] Example 4: Study of inflammatory effects

[0085] To ensure that the topical administration of the drug prepared by the present invention is safe and harmless, two groups of rabbits (n = 3) including a target group (a fiber pack treated with a drug in the intravaginal method) and a control group (a fiber pack treated with no drug) were studied by histological study. Therefore, a fiber pack containing a drug and a fiber pack without a drug were placed in the vagina of the target group and the control group every day and left for 24 hours for 14 days. After 14 days, tissue samples were taken from the vaginal area of ​​these animals and slides were prepared. The prepared slices of the incision were studied by optical microscopy. Figure 4 The histological results of samples prepared from vaginal tissues are shown. The results showed that the herbal disinfectant composition, target group (Fig.-4, d, e and f) did not induce any significant allergic inflammatory response in these animals as compared to the target group (Fig.-4, a, b and c).

[0086] Example 5: Patient treatment methods and clinical trials

[0087] Each complete drug pack consists of 14 fiber packs, and the patient places one in the vagina for up to 24 hours a day (15-24 hours), then removes it and uses another pack. To completely treat vaginitis, the patient should use the fiber packs for 14 days as described above. For chronic infections or pelvic inflammatory disease, treatment can continue for several courses (6-8 months) until the desired effect is achieved. According to field studies, several courses of use of this drug cause no or minimal side effects to volunteers and patients.

[0088] This fiber pack was tested on 30 patients after obtaining their acquiescence regarding drug allergy and effectiveness testing. The patients did not experience any side effects. In addition, recovery of patients affected by vaginal infections was confirmed after one or several courses of use.

Claims

1. A herbal disinfectant composition comprising: Citrus aurantium, myrrh, myrtle and rose, wherein the herbal disinfecting composition comprises Citrus aurantium with a weight content of 30%, myrrh with a weight content of 20%, myrtle with a weight content of 30% and rose with a weight content of 20% in the final component.

2. The herbal disinfectant composition according to claim 1, wherein the herbal disinfectant composition comprises fruits of Citrullus vulgaris, at least one of flowers, buds, petals or stems of rose or a mixture thereof, at least one of leaves, fruits or gums of Myrrh or a mixture thereof, and at least one of leaves or fruits of Myrtle or a mixture thereof.

3. The herbal disinfectant composition according to claim 1, further comprising a pharmaceutical carrier, including a liquid or solid filler, stabilizer, dispersant, suspending agent, diluent, excipient, consolidating agent, solvent or embedding agent.

4. A fiber bag for administering herbs, comprising: a cylindrical body; a rope with two ends, the rope being connected to the cylindrical body from one end; and a middle portion, wherein the middle portion is configured to receive the herbs, wherein: The herbal medicine comprises a mixture of dry plants including Citrus aurantium with a content of 30% by weight in the final medicine, Myrrh with a content of 20% by weight, Myrtle with a content of 30% by weight and Rosa candidum with a content of 20% by weight.

5. The fiber package according to claim 4, wherein: The Chinese herbal medicine is in the form of powder, granules or microgranules.

6. The fiber package of claim 4, wherein the cylindrical body comprises a non-woven or woven single or multiple layer of fibers.

7. The fiber package of claim 4, wherein the cylinders are woven fibers in a plain, non-pile, low-pile, or high-pile form.

8. The fiber package according to claim 4, wherein: The shapes of the cylinder include cone, cylinder, sphere, circle, pearl, bullet or teardrop.

9. The fiber package of claim 4, comprising an applicator, wherein the applicator has a holder and a handle, wherein the cylinder is placed inside the holder.

Citation Information

Patent Citations

  • Tampon capable of killing vaginal mould

    CN108524622A