CN117338844A - Composition for preventing and eliminating human papilloma virus and treating cervical intraepithelial neoplasia, preparation method and application - Google Patents
Composition for preventing and eliminating human papilloma virus and treating cervical intraepithelial neoplasia, preparation method and application Download PDFInfo
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- CN117338844A CN117338844A CN202311320659.0A CN202311320659A CN117338844A CN 117338844 A CN117338844 A CN 117338844A CN 202311320659 A CN202311320659 A CN 202311320659A CN 117338844 A CN117338844 A CN 117338844A
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Abstract
The invention discloses a composition for preventing and eliminating human papilloma virus and treating cervical intraepithelial neoplasia, a preparation method and application thereof, wherein the composition for treating human papilloma virus and cervical intraepithelial neoplasia comprises the following traditional Chinese medicine raw materials in parts by weight: 2-30 parts of boxwood, 2-30 parts of fevervine, 2-30 parts of bufo gargargarizans, 2-20 parts of radix sophorae flavescentis, 2-15 parts of fructus cnidii, 1-10 parts of chicory and 1-10 parts of coptis chinensis. The invention can prevent and eliminate human papilloma virus and can also be used for cervical intraepithelial neoplasia.
Description
Technical Field
The invention relates to a medicine for preventing and eliminating Human Papilloma Virus (HPV) and treating Cervical Intraepithelial Neoplasia (CIN), and the composition can be used for preparing proper preparations, in particular to a composition for preventing and eliminating human papilloma virus and treating cervical intraepithelial neoplasia, and a preparation method and application thereof.
Background
Because HPV can cause a plurality of benign proliferative diseases of skin and mucous membrane, cervical cancer, head and neck cancer, anorectal tumor and the like, pathologists at present find that HPV virus particles are found even in malignant tumors such as lung cancer, gastric cancer, esophagus cancer and the like, so that the HPV has great health hazard, and the HPV infection is not classified into men and women, and the damage is the greatest.
Epidemiological data show that 100% of cervical cancer patients have positive high-risk HPV detection and 97% of cervical intraepithelial high-grade neoplasia detection, so that HPV infection is closely related to cervical cancer, and therefore, the early diagnosis and treatment of HPV infection are of great medical and social significance in prevention and control of cervical cancer.
The research shows that the age distribution of the high-risk HPV infection rate shows the phenomenon of rising after rising, and the age curve shows obvious double-peak characteristics and accords with the cervical cancer high-incidence double-peak curve. A investigation aiming at the HPV infection condition of women aged 15-59 shows that the high-risk HPV infection has the same age difference, peaks are respectively reached between 15-24 and 35-49 years old, and the low-risk HPV infection has no obvious age difference.
The infecting person, especially the infecting person of high risk HPV, need to adopt the normal treatment of thought of both men and women in time, but hardly have the medicine that is used for clearing HPV to be used for clinic in clinical practice, only use interferon etc. to be used for HPV infection's treatment, it is difficult to reach ideal clinical effect, so the clinical urgent need is to fill the blank in safe and effective treatment mode, the research and development of HPV treatment composition has definite social benefit and innovation.
Therefore, the research of the preparation for HPV is very significant in meeting the requirements of high HPV infection rate and the deficiency of clinical treatment means, so the research of the composition has the significance of meeting the clinical requirements.
Patent application No. 201910193919.X discloses a composition for preventing and eliminating Human Papillomavirus (HPV), mainly composed of celosia-back, root of rehmannia, kuh-seng, cnidium fruit, chicory, coptis root, and/or burdock, and/or plantain seed, and/or venenum Bufonis. The composition of the invention can be used for preparing proper preparations and is widely applied to the treatment fields of preventing and eliminating Human Papilloma Virus (HPV) diseases. The invention is based on the patent (application number 201910193919. X) of the present company application of 2019, namely a composition for preventing and eliminating Human Papilloma Virus (HPV), which is further perfected and researched, compared with the original composition, the invention further improves the effect of eliminating HPV, and simultaneously can quickly reverse Cervical Intraepithelial Neoplasia (CIN), and belongs to a result which is needed in clinical urgent need.
The patent with publication number CN105641448A relates to an application of a green and cough and asthma tablet in preparing a medicament for inhibiting the proliferation of cervical cancer cells U14 and a preparation method of the green and cough and asthma tablet. The green and cough and asthma tablet is prepared from 200g of achnatherum gracile, 200g of fevervine, 100g of mahonia stem, 100g of marsdenia tenacissima, 100g of rhizoma bletillae, 100g of polygonum cuspidatum, 100g of garden balsam stem and 100g of rhizoma polygonati by adopting supercritical extraction as raw material medicines, so that the content of emodin is greatly improved.
The patent with publication number CN103288912A relates to a fumarate of a buxine and a derivative or a pharmaceutically acceptable solvate thereof and application thereof in preparing medicaments for treating cancers.
The patent with publication number CN103768344B relates to an external medicine for treating cervical cancer, and the active ingredients of the external medicine consist of, by weight, 3-6 g of gallnut, 3-6 g of brucea javanica, 3-6 g of raw aconite, 13-17 g of dark plum charcoal, 7.5-10.5 g of natural indigo, 2-4 g of borneol, 4.5-7.5 g of benzoin, 4.5-7.5 g of bezoar, 11.5-12.5 g of centipede, 8.5-10.5 g of scorpion, 8.5-10.5 g of dragon's blood, 4-8 g of lithospermum and 5.5-6.5 g of toad. The cervix uteri is exposed to visual field by vagina dilator, and the medicine powder dipped by cotton swab is smeared on cancerous part of cervix uteri once a day. And (3) observation: some patients begin to shrink after 3 days, and the mass of the patients is continuously administrated for one to three months, wherein 22 patients with mass disappearing in 36 cervical cancer patients account for 61.1%; the mass of the medicine is reduced by 12 persons, the mass of the medicine is 33.3%, the mass of the medicine is unchanged by 2 persons, the total effective rate of the medicine is 94.4%, wherein the toad medicine is an animal medicine secreted from the posterior glands of toad ears.
The above patents are all used for treating cervical cancer, are mainly used for killing or inhibiting the growth of cancer cells locally, and are completely different from the treatment thinking of the cervical cancer, which is applicable to the removal of HPV virus and cervical intraepithelial neoplasia.
Disclosure of Invention
The invention aims to solve the technical problems of the prior art, and provides a composition for preventing and eliminating Human Papilloma Virus (HPV) and Cervical Intraepithelial Neoplasia (CIN) as well as a preparation method and application thereof.
In order to solve the technical problems, the invention adopts the following technical scheme: a composition for preventing and eliminating human papilloma virus and cervical intraepithelial neoplasia comprises the following traditional Chinese medicine raw materials in parts by weight: 2-30 parts of boxwood, 2-30 parts of fevervine, 2-30 parts of bufo gargargarizans, 2-20 parts of radix sophorae flavescentis, 2-15 parts of fructus cnidii, 1-10 parts of chicory and 1-10 parts of coptis chinensis.
In a preferred embodiment of the present invention, the composition for preventing and eliminating human papilloma virus and cervical intraepithelial neoplasia comprises the following traditional Chinese medicine raw materials in parts by weight: 5-20 parts of boxwood, 5-20 parts of fevervine, 5-20 parts of toad grass, 5-15 parts of radix sophorae flavescentis, 2-10 parts of fructus cnidii, 1-5 parts of chicory and 1-5 parts of coptis chinensis.
The traditional Chinese medicine belongs to the category of 'leukorrhagia' according to the symptoms of HPV infected patients, and patients have poor healthy qi and spleen movement, so that damp turbidity is generated internally, damp is stagnated to transform heat, and damp heat is downwards injected; the invasion of pathogenic toxin, the healthy qi not against the pathogenic factor, damp-heat and pathogenic toxin stasis in cells Gong Zimen, the impairment of thoroughfare and conception vessels, and the loss of the pulse cause leukorrhagia due to dirty products or unclean sexual intercourse. The treatment takes the basic principle of activating blood circulation to dissipate blood stasis, clearing heat and detoxicating, eliminating dampness and promoting tissue regeneration, strengthening body resistance and eliminating evil.
The boxwood in the composition has the effects of promoting blood circulation, removing blood stasis, detoxifying, eliminating dampness, diminishing inflammation, relieving pain, enhancing organism immunity and increasing physique; herba Paederiae has effects of promoting blood circulation, eliminating dampness, relieving swelling and pain, and enhancing immunity; bufo siccus (herba Salviae Plebeiae) has effects of clearing heat, removing toxic substances, cooling blood, and promoting diuresis. The three drugs are all monarch drugs, and are used for treating the pathogenesis of 'leukorrhagia' in traditional Chinese medicine under HPV factors. The kuh-seng has the effects of clearing heat and drying dampness, dispelling wind and killing parasites; fructus Cnidii has effects of eliminating dampness, dispelling pathogenic wind, killing parasites and relieving itching, and both medicines are ministerial medicines. Chicory has the effects of inducing diuresis and reducing edema; coptidis rhizoma has effects of clearing heat and detoxicating. The two medicines are used as assistant and guide medicines, and together assist and guide medicines, play roles in promoting blood circulation and removing blood stasis, eliminating dampness and detumescence, detoxifying and promoting tissue regeneration, and strengthening body resistance and consolidating constitution, and directly inhibit DNA replication of HPV virus, so that the virus is inactivated or the virus activity is reduced, and invasion of the virus to basal cells of mucous membrane layers is prevented. Basal lamina cells die as a result of infection with viruses, and the dual effects of normal metabolism of the body and the product promote apoptosis while reversing pathological changes in CIN. In conclusion, the invention can resist HPV virus invasion, replication and damaged mucous membrane cell apoptosis repair, effectively remove HPV and reverse CIN.
The invention is based on the patent with the application number of 201910193919.X, namely, radix sophorae flavescentis, fructus cnidii, chicory and coptis chinensis, and newly adds the Chinese medicine 'leukorrhagia' under HPV factors, namely, the boxwood, the fevervine and the bufo siccus as monarch drugs.
Although the folk boxwood is used for treating cardiovascular diseases, malaria, syphilis, rheumatism, dermatitis, rabies and the like, the soaking liquid of the Chinese medicinal herb is used for treating early syphilis, diminishing inflammation of vagina and contracting vagina in a sitting manner, so that a better curative effect is obtained. The alkaloid component is researched, and the alkaloid component has better effects on angina pectoris, arrhythmia and cardiac insufficiency. Further studies have shown that the medicament can treat skin diseases such as erythema nodosum, psoriasis and urticaria, and can also treat diabetic foot complicated infections.
The present non-professional report that the boxwood is used for treating cardiovascular and cerebrovascular diseases, skin bacteria, respiratory viruses and rabies viruses is not used for mucous membrane type and skin type HPV viruses, and the research findings and the reported mechanism of the invention are different, so that the application of the boxwood in HPV virus elimination and cervical intraepithelial neoplasia belongs to the first research findings.
Although antiviral agents such as: 1. nucleosides: nucleoside analogues are classified into non-ring-opening and ring-opening antiviral drugs according to their structure; 2. non-nucleosides; 3. protease inhibitors: saquinavir (Saquinavir), indinavir (Indinavir) Nelfinavir (Nelfinavir); 4. other types: ribavirin (Ribavirin), amantadine hydrochloride (Amantadine Hydrochloride), rimantadine hydrochloride, and the like. However, no literature reports that the existing antiviral drugs have clear effects on HPV viruses, which indicates that the common antiviral drugs have no clinical effects whether blood administration or local administration is performed. Therefore, the effect of removing HPV virus in the invention can not be realized by common antiviral drugs.
However, since the traditional Chinese medicine has no theory of HPV virus infection, HPV infection is classified as 'leukorrhagia' according to some common symptoms, and the common treatment mechanism of the leukorrhagia is mainly as follows: 1. clearing heat and detoxicating: the traditional Chinese medicine treatment usually adopts gynecological medicines for clearing heat and detoxicating, treats the disease causes, eliminates pathogenic bacteria, accelerates the resolution of inflammation and relieves symptoms; 2. regulating qi and blood: the traditional Chinese medicine treatment usually adopts a method of regulating qi and blood, so as to strengthen the immunity of the body and improve the disease resistance of the organism. The composition provided by the invention is mainly used for inhibiting and eliminating viruses and treating abnormal mucous membrane cell apoptosis aiming at gynecological diseases infected by HPV virus in modern researches, and is different from the common concept of treating leukorrhagia. Thus, the present invention does not motivate the use of other drugs for treating leukorrhagia. Experiments show that the composition of the invention can effectively remove HPV and reverse CIN by adding the buxine, and combining with the actions of kuh-seng, fructus cnidii, chicory and coptis together with the fevervine and bufadience which are monarch drugs.
In addition, the weight proportion of the traditional Chinese medicine raw materials in the invention can obviously promote the prevention and removal of human papilloma virus. Reversing cervical intraepithelial neoplasia.
Wherein, the bufo gargargargarizans is also called common sage herb and is a herbal medicine.
In a preferred embodiment of the present invention, the composition for preventing and eliminating human papilloma virus and cervical intraepithelial neoplasia further comprises the following traditional Chinese medicine raw materials in parts by weight: 1-10 parts of venenum bufonis, and the addition of the venenum bufonis is helpful for improving the clearance rate of HPV viruses.
In a preferred embodiment of the present invention, the composition for preventing and eliminating human papilloma virus and cervical intraepithelial neoplasia is 1 to 5 parts by weight of the toad venom.
The invention also discloses a preparation method of the composition gel, which comprises the following steps:
s1, decocting radix sophorae flavescentis, fructus cnidii, chicory and coptis chinensis in water, mixing filtrates, filtering, and concentrating into thick paste;
s2, extracting boxwood, herba Paederiae and Bufo siccus with ethanol under reflux, filtering to obtain extractive solution, recovering ethanol from the extractive solution, drying, and pulverizing to obtain extract;
s3, mixing the thick paste in the S1 and the extract in the S2, adding water with the dosage of 8-12 times, adding carbomer with the total volume of 1-3%, fully and uniformly mixing, and regulating the pH value to 4.0-6.5 to obtain the gel of the composition.
The composition of the invention is prepared into gel, so that not only can the effective components in the composition be fully extracted, but also the composition is convenient for external use.
In a preferred embodiment of the present invention, the water-adding decoction in S1 is water-adding the composition by 4-8 times mass, and the decoction is performed for 1-3 times each time for 2-4 hours.
In a preferred embodiment of the present invention, the reflux extraction in S2 is performed by adding 4 to 6 times of the mass of ethanol to the composition, and extracting at 40 to 60 ℃ for 1.0 to 3.0 hours, and 1 to 2 times.
In a preferred embodiment of the invention, the mass concentration of ethanol is 70-80%.
The invention also discloses application of the composition in treating cervical intraepithelial neoplasia, and removing or preventing human papilloma virus.
Compared with the prior art, the invention has the following beneficial effects:
(1) The composition of the invention can be used in a susceptible environment to effectively prevent the infection from being invaded by HPV, and an infected person can start to inhibit the replication of Human Papilloma Virus (HPV) within three days after taking the composition. The composition provided by the invention has the advantages of controllable quality, convenience and safety in use and suitability for industrial production.
(2) The raw materials in the composition mainly comprise natural medicinal materials, and main active ingredients are separated; the traditional Chinese medicine composition has the advantages of treating both symptoms and root causes, repairing both inside and outside, being mild in medicine property, safe and effective, preventing and removing HPV, repairing local inflammation tissues, thoroughly preventing re-infection of HPV, preventing and removing HPV, and being capable of being used for preventing and treating Cervical Intraepithelial Neoplasia (CIN).
(3) The composition raw materials for Human Papilloma Virus (HPV) and Cervical Intraepithelial Neoplasia (CIN) are prepared into proper preparations by extracting active ingredients of medicinal materials through conventional and/or non-conventional extraction means, and the preparation is used for preventing and eliminating and treating Human Papilloma Virus (HPV) diseases, plays a role in the principle of external treatment of traditional Chinese medicine, is safe and effective in long-term use, completely meets the green requirement, and has obvious innovative and industrialized social benefits.
Detailed Description
The invention is further described below in conjunction with the detailed description. It is to be understood that these examples are illustrative of the present invention and are not intended to limit the scope of the present invention. Further, it is understood that various changes and modifications of the present invention may be made by those skilled in the art after reading the description of the present invention, and that such equivalents are intended to fall within the scope of the claims appended hereto.
Example 1:
prescription: 5 parts of boxwood, 5 parts of fevervine, 5 parts of bufo gargargarizans, 5 parts of radix sophorae flavescentis, 2 parts of fructus cnidii, 1 part of chicory and 1 part of coptis chinensis.
Step 1, taking radix sophorae flavescentis, fructus cnidii, chicory and coptis chinensis, decocting with 6 times of water for 2 times, each time for 3 hours, combining filtrate, filtering, and concentrating to thick paste.
Step 2, extracting the boxwood, the fevervine and the toad grass with 5 times of 75% ethanol at 50 ℃ for 2.0 hours under reflux, extracting for 1 time, filtering to obtain a leaching solution, recovering the ethanol from the leaching solution, drying and crushing to obtain the extract.
And 3, mixing the extracts obtained in the steps 1 and 2, adding water with the dosage of 10 times, adding carbomer with the total volume of 2%, fully and uniformly mixing, and regulating the pH value to 4.0-6.5 to obtain the gel of the composition.
Example 2:
prescription: 10 parts of boxwood, 10 parts of fevervine, 10 parts of bufo gargargarizans, 10 parts of radix sophorae flavescentis, 5 parts of fructus cnidii, 3 parts of chicory and 3 parts of coptis chinensis.
Step 1, taking radix sophorae flavescentis, fructus cnidii, chicory and coptis chinensis, decocting with 8 times of water for 2 times, each time for 2 hours, combining filtrate, filtering, and concentrating to thick paste.
Step 2, extracting the boxwood, the fevervine and the toad grass with 5 times of 85% ethanol at 50 ℃ under reflux for 1.5 hours for 1 time, filtering to obtain a leaching solution, recovering the ethanol from the leaching solution, drying and crushing to obtain the extract.
And step 3, mixing the extracts obtained in the steps 1 and 2, adding water and proper auxiliary materials with the dosage of 10 times, fully and uniformly mixing, and regulating the pH value to 4.0-6.5 to obtain the liquid preparation of the composition.
Example 3:
prescription: 20 parts of boxwood, 20 parts of feverfew, 20 parts of bufo gargargarizans, 15 parts of radix sophorae flavescentis, 10 parts of fructus cnidii, 5 parts of chicory and 5 parts of coptis chinensis.
Step 1, taking radix sophorae flavescentis, fructus cnidii, chicory and coptis chinensis, decocting with 10 times of water for 2 times, each time for 1 hour, combining the filtrates, filtering, and concentrating to thick paste.
Step 2, extracting the boxwood, the fevervine and the toad grass with 5 times of 95% ethanol at 50 ℃ under reflux for 1.0 hour for 1 time, filtering to obtain a leaching solution, recovering the ethanol from the leaching solution, drying and crushing to obtain the extract.
And step 3, mixing the extracts obtained in the steps 1 and 2, adding a proper amount of auxiliary materials, fully and uniformly mixing, adjusting the pH value to 4.0-6.5, and pressing to obtain the suppository of the composition.
Example 4:
prescription: 5 parts of boxwood, 5 parts of fevervine, 5 parts of bufo gargargarizans, 5 parts of radix sophorae flavescentis, 2 parts of fructus cnidii, 1 part of chicory, 1 part of coptis chinensis and 1 part of venenum bufonis.
Step 1, taking radix sophorae flavescentis, fructus cnidii, chicory and coptis chinensis, decocting with 8 times of water for 2 times, each time for 2 hours, combining filtrate, filtering, and concentrating to thick paste.
And 2, cleaning the toad venom to remove impurities, extracting with 5 times of 85% ethanol at 50 ℃ for 1.5 hours under reflux, extracting for 1 time, filtering to obtain a leaching solution, recovering ethanol from the leaching solution, separating, drying and crushing to obtain the extract.
And 3, extracting the boxwood, the fevervine and the bufo gargargarizans with 5 times of 75% ethanol at 50 ℃ for 2.0 hours under reflux for 1 time, filtering to obtain a leaching solution, recovering the ethanol from the leaching solution, drying and crushing to obtain the extract.
And 4, mixing the extracts in the steps 1, 2 and 3, adding water with the dosage of 10 times, adding carbomer with the total volume of 2%, fully and uniformly mixing, and regulating the pH value to 4.0-6.5 to obtain the gel of the composition.
Example 5:
prescription: 10 parts of boxwood, 10 parts of fevervine, 10 parts of bufo gargargarizans, 10 parts of radix sophorae flavescentis, 5 parts of fructus cnidii, 3 parts of chicory, 3 parts of coptis chinensis and 3 parts of venenum bufonis.
Step 1, taking boxwood, herba Paederiae, bufo siccus, radix Sophorae Flavescentis, fructus Cnidii, herba Cichorii and Coptidis rhizoma, decocting with 6 times of water for 2 times each time for 3 hours, mixing filtrates, filtering, and concentrating to obtain soft extract.
And 2, cleaning the toad venom to remove impurities, extracting with 5 times of 75% ethanol at 50 ℃ for 2.0 hours under reflux, extracting for 1 time, filtering to obtain a leaching solution, recovering ethanol from the leaching solution, separating, drying and crushing to obtain the extract.
And step 3, mixing the extracts in the steps 1 and 2, adding a proper amount of auxiliary materials, fully and uniformly mixing, regulating the pH value to 4.0-6.5, and smearing to obtain the film agent of the composition.
Example 6:
prescription: 20 parts of boxwood, 20 parts of fevervine, 20 parts of bufo gargargarizans, 15 parts of radix sophorae flavescentis, 10 parts of fructus cnidii, 5 parts of chicory, 5 parts of coptis chinensis and 5 parts of venenum bufonis.
Step 1, taking boxwood, herba Paederiae, bufo siccus, radix Sophorae Flavescentis, fructus Cnidii, herba Cichorii and Coptidis rhizoma, decocting with 8 times of water for 2 times each time for 2 hours, mixing filtrates, filtering, and concentrating to obtain soft extract.
And 2, cleaning the toad venom to remove impurities, extracting with 5 times of 85% ethanol at 50 ℃ for 1.5 hours under reflux, extracting for 1 time, filtering to obtain a leaching solution, recovering ethanol from the leaching solution, separating, drying and crushing to obtain the extract.
And step 3, mixing the extracts obtained in the steps 1 and 2, adding water with the dosage of 10 times and proper foaming agent, fully and uniformly mixing, and regulating the pH value to 4.0-6.5 to obtain the foaming agent of the composition.
Comparative example 1: a gel made according to the patent of "a composition for preventing and eliminating Human Papillomavirus (HPV)" filed by the company at 3 months 2019 (application No. 201910193919. X).
TABLE 1 parts by weight of compositions in various embodiments of the invention
Effect observation of the composition of the present invention on treatment of high risk HPV infection combined with CINI grade I clinical volunteers
(1) Data and method
1.1 general data
160 cases of high-risk HPV infection combined with CIN I-grade compliant patient volunteers from 1 month in 2020 to 12 months in 2022 are selected, and randomly divided into four groups of 40 cases, wherein the average age (36.41+/-7.55) of the control group is as old as the average course (13.73+/-7.90) of the control group; study of a group of average age (36.38 + -6.92) years, average course (13.94+ -8.05) months; study group average age (36.82 ±6.82) years, average course (14.13±8.12) months; three groups were studied for mean age (37.84.+ -. 7.18) years, mean course (14.08.+ -. 7.97) months. Dialectical standard: main symptoms are as follows: the leucorrhea is more, the color is light yellow or white, the quality is thin or slightly sticky, and no odor exists; secondary symptoms: anorexia, distention, tiredness, debilitation, sallow complexion, edema, abnormal stool (loose stool, loose stool after hard or loose stool after hard time); tongue pulse: pale tongue, swollen tongue with teeth marks, thin and white coating, and thready and weak pulse or wiry and thready pulse. Has the main symptoms and accords with more than or equal to 2 times of symptoms, and the syndrome can be distinguished as spleen deficiency syndrome by combining tongue pulse.
1.2 method of viewing
Control group: treatment with recombinant human interferon alpha 2a suppository (trade name: changsheng De Jia, 50 ten thousand IU/Zhi, manufactured by China Changchun biological products research, all of the company Limited). After 3 days of clean menstruation, urine is emptied before sleep (preventing effect of drug outflow caused by night), after vulva is cleaned, a disposable thin film finger stall is put on, a recombinant human interferon alpha 2a plug is put into the deep part of a fornix behind vagina by an index finger, 12 menstrual cycles are separated for 1 time, no drug can be used in an example period, 3 menstrual cycles are used continuously, any sexual life is forbidden in the period, and HPV clearance rate and CINI (essential oil) reportation condition are checked 14 days after the drug is used.
Study group: gel treatment with the present composition was performed as indicated (example 4). After menstrual period is clean for 3 days, urine is emptied before sleeping (preventing effect of drug outflow caused by night), after vulva is cleaned, drug administration is started, 1 time per night is performed, a patient takes a recumbent position, buttocks are raised, a propeller is gently fed deep into vagina to fornix part, a propeller is taken out after a propeller tube plug is used for injecting gel completely, the propeller cannot be used in an example period, 3 menstrual cycles are used, any sexual life is forbidden in the period, and HPV clearance is checked 14 days after the use of the medicine.
Study two groups: gel treatment with the present composition was performed as indicated (example 1). After menstrual period is clean for 3 days, urine is emptied before sleeping (preventing effect of drug outflow caused by night), after vulva is cleaned, drug administration is started, 1 time per night is performed, a patient takes a recumbent position, buttocks are raised, a propeller is gently fed deep into vagina to fornix part, a propeller is taken out after a propeller tube plug is used for injecting gel completely, the propeller cannot be used in an example period, 3 menstrual cycles are used, any sexual life is forbidden in the period, and HPV clearance is checked 14 days after the use of the medicine.
Three groups were studied: comparative example 1 gel treatment was made according to the patent of "a composition for preventing and eliminating Human Papillomavirus (HPV)" filed by the company at month 3 of 2019 (application No. 201910193919. X). After menstrual period is clean for 3 days, urine is emptied before sleeping (preventing effect of drug outflow caused by night), after vulva is cleaned, drug administration is started, 1 time per night is performed, a patient takes a recumbent position, buttocks are raised, a propeller is gently fed deep into vagina to fornix part, a propeller is taken out after a propeller tube plug is used for injecting gel completely, the propeller cannot be used in an example period, 3 menstrual cycles are used, any sexual life is forbidden in the period, and HPV clearance is checked 14 days after the use of the medicine.
1.3 observations
Standard of efficacy: clinical efficacy is assessed according to HPV-DNA detection, histopathology and "guidelines for clinical research on New Chinese medicine" and "diagnostic efficacy Standard for Chinese medical symptoms". And (3) curing: HPV turns negative, the cytology detection result is negative, and the integral reduction of traditional Chinese medicine symptoms is more than or equal to 95%; the effect is shown: HPV turns negative, the result of cytology detection is positive, the result of pathology histology is negative, the integral of the traditional Chinese medicine symptoms is reduced by less than 95% and 70%; the method is effective: HPV turns negative, cytological detection and pathological histology results are positive, and the integral of the traditional Chinese medicine symptoms is reduced by less than 70% and more than 30%; invalidation: HPV positivity and integral reduction of traditional Chinese medicine symptoms is less than 30%.
TABLE 2 clinical efficacy of inventive examples 1, 4, comparative example 1 and control group
Note that: the evaluation index of the invention is different from the evaluation index of the patent with the application number of 201910193919.X, the special negative conversion rate (%) of the sample is used as the evaluation index, and the evaluation index refers to that HPV infected by the volunteers in the group completely turns negative and is called negative conversion rate; while 94.73% of the patents in the application No. 201910193919.X contain 89.47% of cure rate (negative conversion rate) and 5.26% of effective rate (negative conversion rate is not divided), the actual negative conversion rate is only 89.47%, so the composition of the present invention is more excellent.
The volunteer experiment shows that the composition of the invention is superior to the patent (application number 201910193919. X) of the application of the company of 3 months 2019, namely, a composition for preventing and eliminating Human Papilloma Virus (HPV), is superior to interferon, has definite effect of preventing and eliminating HPV and reverses Cervical Intraepithelial Neoplasia (CIN).
The composition has effects of preventing and eliminating Human Papilloma Virus (HPV) diseases, treating and reversing Cervical Intraepithelial Neoplasia (CIN).
Compared with similar products, the composition has the advantages of excellent and easily obtained raw materials, definite curative effect, simplicity, high efficiency, safety, lower cost, simple operation, strong popularization and wide application prospect.
The foregoing is only a preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any changes or substitutions easily contemplated by those skilled in the art within the scope of the present invention should be included in the scope of the present invention. Therefore, the protection scope of the present invention should be subject to the protection scope of the claims.
Although embodiments of the present invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made therein without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.
Claims (9)
1. The composition for preventing and eliminating human papilloma virus and cervical intraepithelial neoplasia is characterized by comprising the following traditional Chinese medicine raw materials in parts by weight: 2-30 parts of boxwood, 2-30 parts of fevervine, 2-30 parts of bufo gargargarizans, 2-20 parts of radix sophorae flavescentis, 2-15 parts of fructus cnidii, 1-10 parts of chicory and 1-10 parts of coptis chinensis.
2. The composition for preventing and eliminating human papilloma virus and cervical intraepithelial neoplasia according to claim 1, characterized by comprising the following traditional Chinese medicine raw materials in parts by weight: 5-20 parts of boxwood, 5-20 parts of fevervine, 5-20 parts of toad grass, 5-15 parts of radix sophorae flavescentis, 2-10 parts of fructus cnidii, 1-5 parts of chicory and 1-5 parts of coptis chinensis.
3. The composition for preventing and eliminating human papilloma virus and cervical intraepithelial neoplasia according to claim 1, further comprising the following traditional Chinese medicine raw materials in parts by weight: 1-10 parts of toad venom.
4. The composition for preventing and eliminating human papilloma virus and cervical intraepithelial neoplasia according to claim 3, wherein the weight parts of the toad venom are 1 to 5 parts.
5. A method of preparing a gel of a composition according to claim 1 or 2, comprising the steps of:
s1, decocting radix sophorae flavescentis, fructus cnidii, chicory and coptis chinensis in water, mixing filtrates, filtering, and concentrating into thick paste;
s2, extracting boxwood, herba Paederiae and Bufo siccus with ethanol under reflux, filtering to obtain extractive solution, recovering ethanol from the extractive solution, drying, and pulverizing to obtain extract;
s3, mixing the thick paste in the S1 and the extract in the S2, adding water with the dosage of 8-12 times, adding carbomer with the total volume of 1-3%, fully and uniformly mixing, and regulating the pH value to 4.0-6.5 to obtain the gel of the composition.
6. The method of preparing a gel composition according to claim 5, wherein the water is added in the step S1 to be decocted for 1 to 3 times each for 2 to 4 hours by adding 4 to 8 times the mass of the water.
7. The method for preparing a gel composition according to claim 6, wherein the reflux extraction in S2 is performed by adding 4 to 6 times of the mass of ethanol to the composition, and extracting at 40 to 60 ℃ for 1.0 to 3.0 hours for 1 to 2 times.
8. The method for preparing a gel composition according to claim 7, wherein the mass concentration of ethanol is 70-80%.
9. Use of a composition according to any one of claims 1-8 for the treatment of cervical intraepithelial neoplasia, for the removal or prevention of human papillomavirus.
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| CN202311320659.0A CN117338844A (en) | 2023-10-12 | 2023-10-12 | Composition for preventing and eliminating human papilloma virus and treating cervical intraepithelial neoplasia, preparation method and application |
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| CN202311320659.0A CN117338844A (en) | 2023-10-12 | 2023-10-12 | Composition for preventing and eliminating human papilloma virus and treating cervical intraepithelial neoplasia, preparation method and application |
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