WO2021123925A1

WO2021123925A1 - Herbal compositions and administration methods for the treatment of infections and inflammation of vulvovaginal and the pelvic organs

Info

Publication number: WO2021123925A1
Application number: PCT/IB2020/055399
Authority: WO
Inventors: Maryam KHAZAEI SANI
Original assignee: Banooye Armaghan Teb
Priority date: 2019-12-15
Filing date: 2020-06-09
Publication date: 2021-06-24
Also published as: DE112020006124T5; CN115066250A

Abstract

The present disclosure is related to a pharmaceutical composition comprising a plurality of herbal compositions and the related administration method for taking care of the vaginal area and pelvic organs of women or treating diseases or disorders of different types of infections related to these areas. This method comprising applying an effective amount of an herbal disinfecting composition to the subject, wherein the herbal disinfecting composition comprises at least one or more plants from the Citrullus colocynthis genus, Commiphora myrrha genus, Myrtus communis genus, and Rosa damascene or a mixture of these plants. The herbal disinfecting composition may administer via a fibrous pack inside the vagina, wherein the fibrous pack comprising a cylindrical body, a string with two ends, and a middle section, wherein the middle section configured to hold the herbal disinfecting composition.

Description

Herbal compositions and administration methods for the treatment of infections and inflammation of vulvovaginal and the pelvic organs

The present disclosure application claims priority from pending Iran Patent Application, Application No. 139850140003008438, filed on December 15, 2019, entitled “Herbal Pharmaceutical Composition for the Treatment of Vulvovaginal Infections and Inflammation and the Female Pelvic Organs”, which is incorporated by reference herein in its entirety.

This application is related to herbal compositions and administration methods for vulvovaginal infection treatment, reviving normal flora of vulvovaginal area, treatment of diseases related to the vagina, or preventing pelvic organ infections or inflammations.

Vulvovaginal infections are infections related to the lower parts of the genitalia that affect the vagina and vulva. These infections commonly exhibit their effects by itching, discomfort, pain, and unusual vaginal discharges. Vulvovaginal infections majorly have bacterial or fungal origins. The infections originated from the presence of protozoa, majorly trichomonas, comprise only 10% of these infections. The bacterial infections comprise about 50-60% of all vulvovaginal infections. The most common microorganisms observed in this type of infection include Gardnerella vaginalis, Gardnerella mobiluncus, Chlamydia trachomatis, Mycoplasma hominis, Peptostreptococcus, or Ureaplasma urealyticum.

About 70% of women experience vulvovaginal fungal infections in their lifetimes. Moreover, fungal infection has been seen in about 40% of women carrying a type of vulvovaginal bacterial infection. These fungal infections commonly include candida infections. The infections related to bacteria and protozoa are treated using antibiotics and anti-parasites derived from nitroimidazole family such as metronidazole, while fungal infections are commonly treated using antifungal drugs from the family of drugs derived from imidazoles such as econazole, miconazole, and fluconazole. Despite all aforementioned medicinal treatments, the statistics demonstrate that half the women who are treated due to vulvovaginal bacterial infection experience a recurrent infection in the next 12 months. It should be mentioned that the antibiotic drugs used for treating infection in women commonly cause the loss of the normal protecting flora of the vaginal area, a fact which causes the return of the disease and the recurrent infection. Accordingly, the management of candida infections highly requires presenting new agents and drugs with antifungal properties.

Therefore, according to said points, the available chemical treatments for vulvovaginal infections and other pelvic organ diseases of women are commonly dissatisfactory and lead to different side effects such as recurrence of the diseases, causing the medical resistance, disturbing the balance in the normal flora, and occurrence of discomfort in other organs such as the stomach, intestine, and liver due to the systemic absorption of the drug. Hence, studies on active agents comprising natural or herbal medicine can be a suitable solution for this problem.

While, some natural or herbal medicine shows different and sometimes undesirable symptoms in high doses or direct administration for therapeutic purposes. Since, there is a need to a composition and an administration method for the vulvovaginal infections and other pelvic organ diseases of women to solve the mentioned drawback.

This summary is intended to provide an overview of the subject matter of this discloser, and is not intended to identify essential elements or key elements of the subject matter, nor is it intended to be used to determine the scope of the claimed implementations. The proper scope of this discloser may be ascertained from the claims set forth below in view of the detailed description below and the drawings.

In one general aspect, the present disclosure is directed to an exemplary method for treatment of a disease related to the vagina, preventing a vulvovaginal, reviving a normal flora of a vulvovaginal area, or preventing other organ infections or inflammations in a subject. The method may include applying an effective amount of an herbal disinfecting composition to the subject, wherein the herbal disinfecting composition may comprise of at least one or more plants from the Citrullus colocynthis genus, Commiphora myrrha genus, Myrtus communis genus, or Rosa damascene or a mixture of these plants.

The above general aspect may have one or more of the following features. In an exemplary implementation, the herbal disinfecting composition may include Citrullus colocynthis species with a 30-50 wt% content, Commiphora myrrha species with a 20-50 wt% content, Myrtus communis species with a 30-50 wt% content, and Rosa damascene species with a 20-50 wt% content in the final composition. In an exemplary implementation, the herbal disinfecting composition may be in a form of a powder, a granule, or a micro-granule. In an exemplary implementation, applying the effective amount of the herbal disinfecting composition may include administration of the effective amount of a vaginal form of the herbal disinfecting composition inside a vagina or a part of vagina of the subject. In an exemplary implementation, the vaginal form may include a fibrous pack. In an exemplary implementation, the subject may be a human. In an exemplary implementation, preventing vulvovaginal may include preventing or stopping the growth of at least one of the microorganisms, wherein the microorganisms may include Trichomonas vaginalis, Candida albicans, Gardnerella vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, or herpes simplex virus. In an exemplary implementation, the disease related to the vagina, may include vaginitis, vaginal discharge, gonorrhea, bacterial vaginosis, sexually transmitted disease, atrophic vaginitis, fungal infection, or genital warts. In an exemplary implementation, the effective amount of the herbal disinfecting composition may be at least one course including at least once a day for at least 14 days

In another general aspect, the present disclosure is directed to an herbal disinfecting composition. The herbal disinfecting composition may include Citrullus colocynthis, Commiphora myrrha, Myrtus communis, and Rosa damascene.

The above general aspect may have one or more of the following features. In an exemplary implementation, the herbal disinfecting composition may include Citrullus colocynthis species with a 30-50 wt% content, Commiphora myrrha species with a 20-50 wt% content, Myrtus communis species with a 30-50 wt% content, and Rosa damascene species with a 20-50 wt% content in the final composition. In an exemplary implementation, the herbal disinfecting composition may include a fruit of Citrullus colocynthis, at least one or a mixture of a flower, a bud, a petal, or a stem of Rosa damascene, at least one or a mixture of a leave, a fruit, or a gum of Commiphora myrrha, and at least one or a mixture of a leave or a fruit of Myrtus communis plants. In an exemplary implementation, the herbal disinfecting composition may further comprise a drug carrier including a liquid or a solid filler, a stabilizer, a dispersing agent, a suspending agent, a diluting agent, an excipient, a consolidating agent, a solvent, or an entrapping agent.

In another general aspect, the present disclosure is directed to a fibrous pack for administrating an herbal medicine. The fibrous pack may include a cylindrical body, a string with two ends, wherein the string may be connected to the cylindrical body from one end, and a middle section, wherein the middle section may be configured to hold the herbal medicine.

The above general aspect may have one or more of the following features. In an exemplary implementation, the herbal medicine may comprise a mixture of dried plants including plants of Citrullus colocynthis species with a 30-50 wt% content, Commiphora myrrha species with a 20-50 wt% content, Myrtus communis species with a 30-50 wt% content, and Rosa damascene species with a 20-50 wt% content in the final medicine. In an exemplary implementation, the herbal medicine may be in a form of a powder, a plurality of granules, or a plurality of micro-granules. In an exemplary implementation, the cylindrical body may comprise of a nonwoven or a woven as single-ply or multi-ply fiber. In an exemplary implementation, the cylindrical body may be the woven fiber in a simple, a non-fuzzy, a low-fuzz, or a high-fuzz form. In an exemplary implementation, the cylindrical body may be in a shape including a conical, a cylindrical, a spherocylinder, a circle, a pearl, a bullet, or a teardrop. In an exemplary implementation, the fibrous pack may further comprise an applicator, wherein the applicator may include a holder and a handle, wherein the cylindrical body may be placed inside the holder.

The drawing figures only demonstrate one or more embodiments in accord with the present teaching, by way of example only, not by way of limitation. Therefore, the drawing figures do not limit the extent of the present disclosure. Also, reference numerals with similar numbers in the figures demonstrate similar or the same elements.

Fig.1A

illustrates a schematic view of an applicator from the side view, consistent with one or more exemplary embodiments of the present disclosure.

Fig.1B

illustrates a schematic view of the applicator from the top view, consistent with one or more exemplary embodiments of the present disclosure.

Fig.2A

illustrates a schematic view of a fibrous pack from the side view, consistent with one or more exemplary embodiments of the present disclosure.

Fig.2B

illustrates a schematic view of the fibrous pack from the front view, consistent with one or more exemplary embodiments of the present disclosure.

Fig.3

illustrates a plot of the herbal disinfecting composition release for four types of the fibrous packs, including the simple weave, vertical weave, low-fuzz weave, and high-fuzz weave, consistent with one or more exemplary embodiments of the present disclosure.

Fig.4

illustrates microscope images of histological investigations on the tissue samples prepared from the vagina of control rabbits treated by the fibrous pack without the herbal disinfecting composition (a, b, and c) and rabbits treated by the fibrous pack comprising the herbal disinfecting composition as inside-vagina (d, e, and f), consistent with one or more exemplary embodiments of the present disclosure.

Detailed Description

In the following detailed description, numerous specific details are set forth by way of examples in order to provide a thorough understanding of the relevant teachings. However, it should be apparent that the present teachings may be practiced without such details. Except for the concepts that are specially defined in the context of the present discloser, all used technical and scientific terms imply the same definition that is understandable by the skilled in the art (the field of present discloser). Here, the attempt is to cite the most preferred materials and methods to conduct relevant teachings, although many similar materials and methods can be used to conduct the teachings of this application. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the present disclosure is defined only by the appended claims.

As used in the description and the claims, the singular forms “a”, “an”, and “the” include plural forms unless the context clearly demand otherwise.

In the present disclosure, the term “disinfecting” or “disinfector” can imply different meanings including antibiotic, antiseptic, antifungal, antibacterial, antiprotozoal, and antivirus properties and or other words with the same concept. These definitions do not only comprise the said instances.

The concepts “antifungal”, “antibacterial”, “antiprotozoal”, or similar terms used in the present disclosure imply the prevention of growth, stopping the population growth of fungi, bacteria, protozoa, or viruses, or decrease in the intensity or the probability of the development of a fungal, bacterial, protozoal, or virus disease. These concepts can also be defined as the death of fungi, bacteria, or protozoa or decrease or inhibiting the pathogenic effects of those fungi, bacteria, or protozoal. The terms bactericide and fungicide can be used instead of the terms antibacterial and antifungal, respectively. In one or more aspects of the present disclosure, the herbal disinfecting composition is of antimicrobial properties. The said term antimicrobial in the present disclosure implies being effective in preventing, inhibiting, or stopping the growth or the pathogenic effects of a microorganism. Microorganism here implies any type of bacterium, virus, fungus, or protozoon.

As used herein, the term “subject” of the herein disclosed methods may include mammals. In a particular embodiment of this disclosure, the subject implies human. In some of the aspects of the present disclosure, the composition disclosed in this application can be used for human subjects with male or female sexuality or for treating infections and inflammations in women or men.

As used herein, the term “plants” of the herein disclosed method may include Citrullus colocynthis species, Commiphora myrrha species, Myrtus communis species, or Rosa damascene species.

As used herein, the term “effective amount” or “effective dose“ of the herein discloser implies an amount that is enough for the desirable or suitable antimicrobial or generally the disinfecting activity includes, but is not limited to, killing microorganisms or inhibiting the microbial infection, inhibiting the growth or toxicity as well. In some embodiments of this disclosure, the concept of “effective amount” implies the amount that is required for decreasing or improving at least one of the signs of diseases compared to an untreated patient. The effective amount of an active agent used for medicinal treatment of a disease is different depending on the administration method, extent of disease, stage of the disease, age, sex, body weight, and the general health condition of the subject.

In the presented composition and treatment method of the present disclosure, the effort was made to treat fungal, bacterial, virus and protozoal infections of vulvovaginal and other pelvic organs including uterus, vulva, and cervix using a new composition of medicinal herbs chosen from the genera including Citrullus genus, Commiphora genus, Rosa genus, and Myrtus genus using given proportions, and using a suitable carrier to deliver the drug topically to the mucus tissue of the vagina. The present disclosure also causes the excretion of infections of the depth of the vagina, uterus, and pelvic organs by diluting them. Hence the present disclosure causes the complete excretion of the infectious and odorous discharges from the vulvovaginal region and, therefore, the complete purge of this region besides treating the infection.

In a general aspect, the present disclosure presents an herbal composition with disinfecting property. In a general embodiment of the present discloser, the herbal disinfecting composition may include at least one or more plants from genera including Citrullus genus with 10-90 wt% content, Commiphora genus with 10-90 wt% content, Myrtus genus with 10-90 wt% content, and Rosa genus with 10-90 wt% content (in the final composition) or a mixture of these plants. In a particular embodiment of the present discloser, the herbal disinfecting composition may include at least one or more plants from genera including Citrullus genus with 30-50 wt% content, Commiphora genus with 20-50 wt% content, Myrtus genus with 30-50 wt% content, and Rosa genus with 20-50 wt% content (in the final composition) or a mixture of these plants.

In one or more embodiments of the present disclosure, Citrullus genus includes the colocynth species with the scientific name Citrullus colocynthis, from the cucurbitaceae family that grows naturally in dry regions. This big plant runner may have hairy leaves, solitary yellow flowers, and round green and white fruits that may turn to yellow when ripe. This plant commonly grows in countries such as Saudi Arabia, Syria, Jordan, Egypt, Iran, India, and Pakistan and is known with names such as colocynth, bitter apple, bitter cucumber, desert gourd, egusi, vine of Sodom, wild gourd, and in the south of Iran it is known as Caspian. The name of the plant used in the present disclosure is not limited only to the said names.

In one or more embodiments of the present disclosure, Commiphora genus includes Mur Makki species with the scientific name of Commiphora myrrha and other species of Commiphora. This plant is also known by names African myrrh, herabol myrrh, Somali myrrhor, common myrrh, or gum myrrh. The name of the plant used in the present disclosure is not limited only to the said names. In one or more embodiments of the present disclosure, Commiphora genus can include other species of this genus, including Commiphora abyssinica, Commiphora schimperi, Commiphora erythraea, and Commiphora molmol as well. The used plant of this genus is not limited only to said instances.

In one or more embodiments of the present disclosure, myrtus genus includes the myrtle species with the scientific name Myrtus communis, belongs to the Myrtaceae family. This plant is also known as “common myrtle”. This plant is a shrub and can grow up to 2-3 m from the ground. The stems of this shrub can grow irregularly and may be covered by a fawn-colored dermal tissue. The leaves of this plant may be green, stiff, and dark green colored. The name of the plant used in the present disclosure is not limited only to the said instances.

In one or more embodiments of the present disclosure, Rosa genus includes the red rose with the scientific name Rosa damascene. This plant is also known with other names such as rose, Damask rose, rose hybrid, Rosa gallica, Rosa moschata, and Rosa fedtschenkoana. The name of the plant used in the present disclosure is not limited only to the said instances.

In one or more aspects of the present disclosure, the herbal disinfecting composition of the present disclosure may be used for prevention or stopping the growth of at least one of the following microorganisms. These microorganisms may include Trichomonas vaginalis, Candida albicans, Gardnerella vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae (GNCO), or herpes simplex virus.

In some embodiments of the present disclosure, the herbal disinfecting composition presented in this disclosure may be used for treating diseases related to the vagina, for example, but not limited to, vaginitis, vaginal discharge, gonorrhea, bacterial vaginosis, sexually transmitted diseases, atrophic vaginitis, fungal infection, genital warts.

In a particular embodiment of the present disclosure, the herbal disinfecting composition with the disinfecting property may comprise one or more plants of the Citrullus colocynthis species with 30-50 wt% content, Commiphora myrrha species with 20-50 wt% content, Myrtus communis species with 30-50 wt% content, and Rosa damascene species with 20-50 wt% (in the final composition) or a mixture of these species.

In one or more embodiments of the present disclosure, the herbal disinfecting composition can comprise one or more of the following: water-soluble extracts of one or more plants, a powder comprising at least one or more dried plants, oil-soluble extracts of at least one or more plants, powder of one or more plants prepared using spray-drying, powder of the extracts in which the protein of irons is hydrolyzed that can include the extracts of one or more plants, essential oil of one or more plants, active agents of one or more plants, powder of pomace or the flesh of peeled fruit of one or more plants, extracts of one or more plants capsulated in liposome and/or extracts of one or more plants encapsulated in a polymer.

In a particular embodiment, one or more of dried plants, including Citrullus colocynthis, Commiphora myrrha, Myrtus communis, or Rosa damascene can be prepared as a powder. Hence in this embodiment, different parts of these plants can be grinded.

In one or more aspects of the present disclosure, to prepare the herbal disinfecting composition, different parts of plants including at least one or a mixture of fruits, leaves, stems, roots, flowers, buds, petals, dermal tissue, gum, resin, or a mixture of them may be used.

In one or more aspects of the present disclosure, to prepare the herbal disinfecting composition, fruits of colocynth may be used.

In one or more aspects of the present disclosure, to prepare the herbal disinfecting composition, at least one or a mixture of flowers, buds, petals, or stems of damask rose may be used.

In one or more aspects of the present disclosure, to prepare the herbal disinfecting composition, at least one or a mixture of leaves or fruits of Myrtus plants may be used.

In one or more aspects of the present disclosure, to prepare the herbal disinfecting composition, at least one or a mixture of leaves, fruits, or the gum of Myrrha plant may be used.

In one or more embodiments of the present disclosure, using the herbal composition presented in this disclosure may limit the possibility of recurrence of disease and recurrent infection, which happens due to the imbalance in the saprophytic flora. Moreover, the developed method for administering this composition not only treats the infection but also purges the environment of the vagina and the excretion of discharges, infections, and drug residues from the vaginal area.

One of the embodiments of the present disclosure is related to the production of the herbal disinfecting composition in the vaginal form and dosage including vaginal ointment, vaginal cream, vaginal gel, vaginal liquid, vaginal emulsion, vaginal suspension, vaginal foam, tampon, vaginal pill, vaginal capsule, vaginal ring, lotion, ovule, vaginal douche, powder, granule, micro-granule, aerosol, film, drop, spray, fibrous pack, and suppository.

In a particular embodiment of the present disclosure, preparing the herbal disinfecting composition may comprise of preparing a powder mixed from dried plants, including Citrullus colocynthis, Commiphora myrrha, Myrtus communis, and Rosa damascene. In another particular embodiment of this disclosure, preparing the herbal disinfecting composition may comprise of preparing a granule, a micro-granule, a plurality of granules, or a plurality of micro-granules, including a powder mixed from dried plants including Citrullus colocynthis, Commiphora myrrha, Myrtus communis, and Rosa damascene. In one or more embodiments of the present disclosure, the powder mixed from the dried plants and/or granules or micro-granules, including Citrullus colocynthis, Commiphora myrrha, Myrtus communis, and Rosa damascene may be administered to the subject using a fibrous pack.

In different embodiments of the present disclosure, in order to prepare the herbal disinfecting composition, one acceptable drug carrier may be used. The suitable drug carrier implies any type of acceptable drug material including liquid or solid fillers, stabilizers, dispersing agents, suspending agents, diluting agents, excipients, consolidating agents, solvents or entrapping agents that have application in carrying or transporting the composition or molecule used in the present disclosure to the body of the subjects so that the composition or the molecule can carry out the expected activity. In one or more embodiments of the present disclosure including the acceptable drug, the carrier may include any kind of coating agent, antibacterial or antifungal agent, and drug absorption moderator agents, and similar instances that need to be compatible with the activity of the herbal disinfecting composition of the present disclosure and be acceptable for the subject physiologically.

The herbal disinfecting composition of the present disclosure can be administered on different surfaces of the body, skin, a bodily cavity, or a mucosal surface, for instance, nose, mouth, eye, ears, respiratory system, vagina or rectum. Also, in some embodiments, the present disclosure can be applied in different forms of administration to the subject.

In one or more aspects of the present disclosure, the treatment method and/or the method of preventing vulvovaginal or other pelvic organ infections and/or inflammations and/or reviving the normal flora of the vulvovaginal area in the intended subject as well may include applying the “effective amount” of the herbal disinfecting composition to the subject. In some embodiments, the herbal disinfecting composition may include at least one or more dried plants from genera including Citrullus genus with 10-90 wt% content, Commiphora genus with 10-90 wt% content, Myrtus genus with 10-90 wt% content, and Rosa genus with 10-90 wt% content (in the final composition) or a mixture of these plants. In a particular embodiment of the present discloser, the herbal disinfecting composition may comprise at least one or more dried plants from the Citrullus colocynthis genus with 30-50 wt% content, Commiphora myrrha genus with 20-50 wt% content, Myrtus communis genus with 30-50 wt% content, and Rosa damascene with 20-50 wt% content (in the final composition) or a mixture of these genera.

In one or more aspects of the present disclosure, the herbal disinfecting composition may be administered through the vagina.

In some embodiments of the present disclosure, the effective amount or effective dose for treatment method using the herbal disinfecting composition, especially in the form of a plurality of granules in a fibrous pack can be 0.5 to 10 gr. In one or more embodiments of the present disclosure, the effective dose for treatment method using the herbal disinfecting composition, especially in the form of a plurality of granules in a fibrous pack, can be daily, particularly at least once a day for 10-24 hours, and more particularly at least once a day for 15-24 hours. In a particular embodiment of the present disclosure, treating vaginitis may include using the herbal disinfecting composition, at least once a day and for at least 4 days, particularly for at least 7 days, and more particularly for at least 14 days. In another embodiment of the present disclosure, treating chronic infections and/or inflammations and/or diseases related to the pelvic organs can comprise using the herbal disinfecting composition at least once a day for at least 14 days, here called a course, and particularly for at least one course or several courses during 6-8 months and/or longer until obtaining favorable results.

In another embodiment of the present disclosure, the effective dose for preventing vulvovaginal or other pelvic organ infections and/or inflammations and/or reviving the normal flora of the vulvovaginal area can be daily, particularly at least once a day for 10-24 hours, and more particularly at least once a day for 15-24 hours, for less than 4 days.

In one or more embodiments of the present disclosure, the effective dose of the herbal disinfecting composition administered to the subject is depended on the route of administration and in powder form is related to particle size. In one or more embodiments of the present disclosure, the effective amount of the herbal disinfecting composition administered to the subject can be in the range of 0.5 to 10 gr, particularly in the range of 2 to 7 gr.

In one or more embodiments of the present disclosure, the herbal disinfecting composition can be administered to the patient using doses and periods that are effective for treating the disease or disturbing or decreasing the signs of the intended disease in the present disclosure. The effective dose of the herbal disinfecting composition that is required for obtaining the treatment effects can be determined according to factors such the type, extent and stage of the disease or disorder in the patient, age, body weight and sex of patient. The dose can be regulated to obtain the optimum treatment response. For instance, the dose can gradually decrease. In some embodiments of the present disclosure, the dosage is divided into several doses or can be administered as daily or special time sequences by decreasing the doses during the time.

In one or more embodiments of the present disclosure, the herbal disinfecting composition can also comprise at least one of the following drugs or compositions or a mixture of them. These instances include all antifungal agents, antibacterial agents, antimicrobial agents, antivirus agents, anti-infectives, spermicides, hormones, antibiotics, analgesics, anti-trichomonas agents, antiprotozoal agents, anti-mycoplasma agents, anti-retrovirus agents, nucleoside analogues, reverse telomerase enzyme (reverse transcriptase), protease inhibitors, anti-fertility agents, steroids, antiemetic agents, dyes, fragrance agents, antihistamines, anti-inflammatory agents, antineoplastics, antioxidants, vitamins, drug absorption promoters, inorganic substances, and herbal extracts with the goal of administration inside the vagina. These drugs and compositions are not only limited to said instances.

In one or more embodiments of the present disclosure, a drug or medical product comprising the herbal disinfecting composition can be administered to a goal spot or goal area, specifically vagina. This drug or medical product comprising the herbal disinfecting composition can be of properties such as disinfecting properties for example, but not limited to, antifungal, antibacterial antiprotozoal, and antivirus properties and also properties including cleaning, pH-regulation, preventing the disease from becoming chronic, the recurrence of the disease or infection, and preventing the imbalance in the normal flora.

A particular embodiment of the present disclosure is related to preparing a kit comprises a fibrous pack for delivering a drug, a medical product, an herbal medicine, or the herbal disinfecting composition to a goal spot or goal area, specifically vagina. The kit can control the drug release and undesirable symptoms in high doses or direct administration of the herbal medicine.

In some embodiments of this disclosure, as shown in Figs.1A and 1B, the kit may comprise of an applicator for easily placing the fibrous pack inside the vagina by the user. In an exemplary embodiment, the applicator may comprise of a holder 101 and a handle 103 itself. A cylindrical body 301 can be placed inside the holder 101 and then placed inside the vagina with the aid of the handle 103.

In one of the embodiments of the present disclosure, as shown in Figs.2A and 2B, the kit may comprise the fibrous pack for administration inside the vagina. The fibrous pack may comprise the cylindrical body 301 that itself may include: 1) the herbal disinfecting composition, including a plurality of herbal compositions and 2) a string with two ends including a first end 303 and a second end 307 , wherein the string may be connected to the cylindrical body 301 from the first end 303. In an exemplary embodiment, the cylindrical body 301 may comprise a middle section, wherein the middle section may comprise the herbal medicine, for example, but not limited to, Nigella sativa, Plantago major, Descurainia Sophia, Chamomile, Alcea Citrullus colocynthis, Commiphora myrrha, Myrtus communis, and Rosa damascene genus.

In a particular embodiment of the present disclosure, the middle section may comprise the herbal disinfecting composition including a mixture of dried plants and particularly in the powder form including plants of Citrullus colocynthis species with a 30-50 wt% content, Commiphora myrrha species with a 20-50 wt% content, Myrtus communis species with a 30-50 wt% content, and Rosa damascene species with a 20-50 wt% content in the final composition. In another embodiment of the present disclosure, the cylindrical body 301 may include a plurality of granules or micro-granules of herbal disinfecting composition including plants of Citrullus colocynthis species with a 30-50 wt% content, Commiphora myrrha species with a 20-50 wt% content, Myrtus communis species with a 30-50 wt% content, and Rosa damascene species with a 20-50 wt% content so that the ratios or composition of these plants is based on the final weight of the granules or micro-granules.

In one or more embodiments of the present disclosure, the cylindrical body 301 may compose of fibers or nanofibers made of animal-based material such as silk or wool, plant-based materials such as cotton, synthetic materials, such as polyester, absorbable material, or a mixture of these materials, so that this body may have a diameter between 0.1-2.5 cm and length of 3-10 cm and can be nonwoven or woven as single-ply or multi-ply particularly including 3-6ply. In another embodiment of the present disclosure, the length of the cylindrical body 301 can be between 5-10 cm. The string that is connected to the cylindrical body 301 by the first end 303, in one or more embodiments of the present disclosure, can be of a length between 5-15 cm. Also, in several embodiments of the present disclosure, the cylindrical body 301 can be prepared as different shapes, for example, but not limited to, conical, cylindrical, spherocylinder, circle, pearl, bullet, and teardrop shapes and in different sizes. The shapes and sizes of the cylindrical body 301 are not limited to only said instances.

In one of the embodiments of the present disclosure, a plurality of granules or micro-granules composed of drugs, the herbal disinfecting compositions, or the herbal medicine may be located at the center of the cylindrical body 301. In another embodiment of the present disclosure, the cylindrical body 301 can be prepared from fibers, so that generally the herbal medicine, the herbal disinfecting composition, or drugs, for instance, in form of granules or micro-granules can be located in between the fibers in the cylindrical body 301. In one of the embodiments of the present disclosure, these fibers may comprise of the herbal medicine or the herbal disinfecting composition. In another embodiment, this cylindrical body 301 may comprise a tampon including the herbal medicine or the herbal disinfecting composition, so that this tampon may be located inside the cylindrical body 301 or at its center. In a particular embodiment of the present disclosure, these fibers can be in woven annular form and comprising of cotton fibers. In other embodiments of this disclosure, these fibers can be woven in annular, horizontal, or vertical forms. In other embodiments of this disclosure, these fibers can be nonwoven or woven in simple, non-fuzzy, low-fuzz, or high-fuzz forms.

The fibrous pack of the present disclosure can be applied on different surfaces of the subject body, skin, mucosal surface, for instance, nose, mouth, ears, respiratory system, different canals of the subject body, Pudendal canal, vagina, rectum, or other organs or systems of the subject body.

The present disclosure comprising the fibrous pack comprising the herbal disinfecting composition was tested on rabbits for investigating toxicity and inflammatory effect. The fibrous packs comprising the herbal disinfecting composition were placed daily and each time for 24 hours in a 14-day course in the vaginas of rabbits of the subject group. Three rabbits were tested as negative-control only with the fibrous pack and without the drug. Fig.4 demonstrates the results of the histology of samples (slides) prepared from the vagina tissue. The results demonstrated that the present herbal disinfecting composition, the object group (Fig.4 images d, e, and f) compared to the control (Fig.4 images a, b, and c) did not cause any significant allergic inflammatory effects in these animals. Also, the investigation of herbal disinfecting composition release for 4 types of the fibrous packs, including simple weave, vertical weave, low-fuzz weave, and high-fuzz weave, demonstrated that the optimum drug release level occurred when the fibrous pack was woven vertically. In this case, after 20 hours, all the content of the drug was released (Fig.3).

In one or more embodiments of the present disclosure, the herbal disinfecting composition is appropriate to the pH of the environment of the vagina that causes the balance in the environment of the vagina and as a result, prevent the recurrence of the disease and does not disturb the balance of the normal flora of the vagina.

In one or more embodiments of the present disclosure, since the herbal disinfecting composition does not absorb systemically and also since this composition has no or minimum side effects, complications in other organs of the body do not occur.

In one or more embodiments of the present disclosure, using this method, all diseases related to vagina including vaginitis, vaginal discharges, gonorrhea, bacterial vaginosis, sexually transmitted diseases, atrophic vaginitis, fungal infection, genital warts and the like can be treated.

In one or more embodiments of the present disclosure, the composition of the granules and the mentioned properties of the fibrous pack presented in this discloser lead to the controlled drug release.

In one or more embodiments of the present disclosure, using fibers as drug carriers can play the role of cleaning the environment of the vagina and pelvic organs.

In one or more embodiments of the present disclosure, using fibers cause the excretion of discharges, infections, residues, remnants, or drug from the environment of the vagina and can cause an effective and high-performance treatment of the vaginal and uterine infections.

In one or more embodiments of the present disclosure, the herbal disinfecting composition present in the disclosure, besides the antibiotic role, have a good potency of penetration in the depth of uterus and pelvic organs and can cause the dissolution of infectious and unnatural discharges in the environment and push the discharges to flow out of the body.

Examples

EXAMPLE 1: HERBAL DISINFECTING COMPOSITION PREPARATION

The plant species, including Citrullus colocynthis, Commiphora myrrha, Myrtus communis, and Rosa damascene, were first obtained and dried.

Gum of Commiphora myrrha, the fruit of Citrullus colocynthis, leaf of Myrtus communis, and the bud of Rosa damascene were ground using an industrial grinder.

The powder of the fruit of Citrullus colocynthis with a 30-50 wt%, gum of Commiphora myrrha with a 20-50 wt%, leaf of Myrtus communis with a 30-50 wt%, and the bud of Rosa damascene with a 30-50 wt% were mixed.

A fibrous pack made from multi-ply (3-6ply) cotton fibers with an annular vertical weave was prepared with a length of 5-10 cm and an area of 2-5 cm as a cone. This pack has a string with an 8-10 cm length in one end that is weaved with the cylindrical body.

2-7 g herbal disinfecting composition was placed as powders in each fibrous pack.

EXAMPLE 2: HERBAL DISINFECTING COMPOSITION PREPARATION

The powder obtained from mixing the powders of the fruit of Citrullus colocynthis with a 30-50 wt%, gum of Commiphora myrrha with a 20-50 wt%, leaf of Myrtus communis with a 30-50 wt%, and the bud of Rosa damascene with a 30-50 wt% were turned into granules with 1-5 cm sizes. Here, after preparing granules, 2-7 g of prepared granules were placed in each fibrous pack.

Granules prepared comprise 8.5 wt% total ash, 4 wt% acid non-soluble ash, and 6-6.6 % moisture, and is of pH=3.83. The moisture content of granules, were investigated through two direct and azeotrope methods

EXAMPLE 3: DRUG RELEASE INVESTIGATIONS

The effect of three modes were investigated in the released drug content. These modes were all related to the effect of the weave of the fibrous pack on the release content and included four types of simple weave, vertical weave, low-fuzz weave, and high-fuzz weave. To conduct this test, the fibrous pack comprising the drug was placed in a buffer with a pH close to the pH of the vagina (pH≈4) with a temperature of 37 °C in a stability test chamber instrument. Sampling from the buffer was carried out during 5-24 hours, and the content of the active agent of the colocynth named colocynthin was measuring using the HPLC method (Fig.3). Results exhibited that the packs woven using the vertical weave method led to the highest drug release. Using this type of weave, all of the content of the drug was released to the environment after 20 hours.

EXAMPLE 4: INVESTIGATION OF THE INFLAMMATION EFFECT

To ensure that the topical administration of the prepared drug in the present disclosure was safe and harmless, two groups of rabbits (n=3) including the object group (the group treated by the fibrous pack comprising the drug in an inside-vagina method) and the control group (the group treated by the fibrous pack without the drug) were investigated by histology studies. Therefore, the fibrous packs comprising the drug and the pack without the drugs were placed in the vagina of the object and control rabbit groups daily and for 24 hours for 14 days. After 14 days, sampling from the tissue of the vaginal area of these animals was carried out, and slides were prepared. Prepared sides of the tissue cuts were investigated by optical microscopy. Fig.4 demonstrates the results of the histology of samples prepared from the vagina tissue. The results demonstrated that the present herbal disinfecting composition, the object group (Fig.4 images d, e, and f) compared to the control (Fig.4 images a, b, and c) did not cause any significant allergic inflammatory effects in these animals.

EXAMPLE 5: PATIENT TREATMENT METHOD AND CLINICAL TRIAL

Each complete drug package comprises 14 fibrous packs, and the patient places one daily inside the vagina for a maximum of 24 hours (15-24 hours) and then removes it and uses another pack. To thoroughly treat vaginitis, the patient uses the fibrous packs for 14 days by the said method. In chronic infections or pelvic inflammatory diseases, the treatment can be continued for several courses (6-8 months) until reaching desirable results. Using several courses of this drug caused no or minimum side effects in volunteer patients according to field studies.

This fibrous pack was also tested on 30 patients after obtaining their acquiescence for allergy and effectivity tests of the drug. No side effect was reported by the patients. Also, the recovery of patients affected with vaginal infections was confirmed after using one or several treatment courses.

Claims

A method for treatment of a disease related to the vagina, preventing a vulvovaginal, reviving a normal flora of a vulvovaginal area, or preventing other organ infections or inflammations in a subject, comprising applying an effective amount of an herbal disinfecting composition to the subject, wherein the herbal disinfecting composition comprises at least one or more plants from the Citrullus colocynthis genus, Commiphora myrrha genus, Myrtus communis genus, or Rosa damascene or a mixture of these plants.
The method of claim 1, wherein the herbal disinfecting composition includes Citrullus colocynthis species with a 30-50 wt% content, Commiphora myrrha species with a 20-50 wt% content, Myrtus communis species with a 30-50 wt% content, and Rosa damascene species with a 20-50 wt% content in the final composition.
The method of claim 1, wherein the herbal disinfecting composition is in a form of a powder, a granule, or a micro-granule.
The method of claim 1, wherein applying the effective amount of the herbal disinfecting composition includes administration of the effective amount of a vaginal form of the herbal disinfecting composition inside a vagina or a part of vagina of the subject.
The method of claim 4, wherein the vaginal form includes a fibrous pack.
The method of claim 1, wherein the subject is a human.
The method of claim 1, wherein preventing vulvovaginal includes preventing or stopping the growth of at least one of the microorganisms, wherein the microorganisms include Trichomonas vaginalis, Candida albicans, Gardnerella vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, or herpes simplex virus.
The method of claim 1, wherein the disease related to the vagina, includes vaginitis, vaginal discharge, gonorrhea, bacterial vaginosis, sexually transmitted disease, atrophic vaginitis, fungal infection, or genital warts.
The method of claim 1, wherein the effective amount is at least one course including at least once a day for at least 14 days.
An herbal disinfecting composition, comprising:
Citrullus colocynthis;
Commiphora myrrha;
Myrtus communis; and
Rosa damascene.
The herbal disinfecting composition of claim 10, wherein the herbal disinfecting composition includes Citrullus colocynthis species with a 30-50 wt% content, Commiphora myrrha species with a 20-50 wt% content, Myrtus communis species with a 30-50 wt% content, and Rosa damascene species with a 20-50 wt% content in the final composition.
The herbal disinfecting composition of claim 10, wherein the herbal disinfecting composition includes a fruit of Citrullus colocynthis, at least one or a mixture of a flower, a bud, a petal, or a stem of Rosa damascene, at least one or a mixture of a leave, a fruit, or a gum of Commiphora myrrha, and at least one or a mixture of a leave or a fruit of Myrtus communis plants.
The herbal disinfecting composition of claim 10, further comprises a drug carrier including a liquid or a solid filler, a stabilizer, a dispersing agent, a suspending agent, a diluting agent, an excipient, a consolidating agent, a solvent, or an entrapping agent.
A fibrous pack for administrating an herbal medicine, comprising:
a cylindrical body;
a string with two ends, wherein the string is connected to the cylindrical body from one end; and
a middle section, wherein the middle section configured to hold the herbal medicine.
The fibrous pack of claim 14, wherein the herbal medicine comprises a mixture of dried plants including plants of Citrullus colocynthis species with a 30-50 wt% content, Commiphora myrrha species with a 20-50 wt% content, Myrtus communis species with a 30-50 wt% content, and Rosa damascene species with a 20-50 wt% content in the final medicine.
The fibrous pack of claim 14, wherein the herbal medicine is in a form of a powder, a plurality of granules, or a plurality of micro-granules.
The fibrous pack of claim 14, wherein the cylindrical body comprises of a nonwoven or a woven as single-ply or multi-ply fiber.
The fibrous pack of claim 14, wherein the cylindrical body is a woven fiber in a simple, a non-fuzzy, a low-fuzz, or a high-fuzz form.
The fibrous pack of claim 14, wherein the cylindrical body is in a shape including a conical, a cylindrical, a spherocylinder, a circle, a pearl, a bullet, or a teardrop.
The fibrous pack of claim 14, further comprising an applicator, wherein the applicator comprises of a holder and a handle, wherein the cylindrical body is placed inside the holder.